Medical policy: Wound and Burn Management and Specialized Treatment Centers

Número de política: MP 4.028

Fecha de entrada en vigor: 2/1/2026

Política

Specialized wound or burn care may be considered medically necessary for the following types of wounds or burns:

• Requiring non-selective or selective debridement to facilitate healing or due to necrotic tissue, including codes 11000, 11001, 11042, 11043, 11044, 11045, 11046, 11047, 97597, 97598, 97602, 0973T-0976T; or
• Requiring complex dressing, including codes 16020, 16025, 16030, 29581, 29584; or
• With documentation of signs of infection or risk factors for infection (e.g., diabetes mellitus, moderate dose of steroids, frail, elderly, poor nutrition, ischemia, venous insufficiency, etc.); or
• Third degree or severe second degree burns.

Documentation requirements for medical necessity

The medical necessity for wound or burn care on a continuing basis for a given wound in a given individual is contingent upon evidence documented in the individual's record that the wound is improving in response to the wound care being provided. Evidence of improvement includes measurable changes in at least two of the following:

• Drainage
• Inflammation
• Swelling
• Pain and/or tenderness
• Wound dimensions (surface measurements, depth)
• Granulation tissue
• Necrotic tissue/slough
• Tunneling or undermining

Such evidence must be documented each time the individual is seen. A wound that shows no improvement after 30 days requires a new approach, which may include a physician reassessment of underlying infection, metabolic, nutritional, or vascular problems inhibiting wound healing, or a new treatment approach.

Specialized wound or burn care is considered investigational in the following circumstances:

• A superficial wound, less than 0.2 mm in depth (i.e., abrasion, road rash, etc.), without documentation of signs of infection;
• A small uncomplicated wound (<0.5 cm square) in an individual without documentation of risk factors for infection (e.g., diabetes mellitus, moderate dose of steroids, frail, elderly, poor nutrition, ischemia, venous insufficiency, etc.) or signs of infection;
• A mild burn (e.g., first degree or small area of second degree);
• There is no documentation of the continued need for debridement, or current wound infection, or complex wounds or dressings;
• The management of acute wounds; the care of wounds that normally heal by primary intention, such as clean, incised traumatic wounds; surgical wounds, which are closed primarily; and other uncomplicated postoperative wound care.

Debridement of the wound(s) if there is no necrotic, devitalized, fibrotic, or other tissue or foreign matter present that would interfere with wound healing is investigational.

Procedures performed for cosmetic reasons or to prepare tissues for cosmetic procedures are considered investigational.

With appropriate management, it is expected that in most cases a wound will reach a state at which care can be performed primarily in a non-specialized office setting, and ultimately by the individual and/or the individual’s caregiver with periodic physician assessment and supervision.

Wound care that can be performed in a non-specialized office setting or by the individual or the individual’s caregiver is considered investigational.

Electrostimulation and electromagnetic therapy

Electrical stimulation for the treatment of wounds including, but not limited to, low-intensity direct current, high-voltage pulsed current, alternating current, and transcutaneous electrical nerve stimulation, is considered investigational.

Electrical stimulation performed by individuals in the home setting for the treatment of wounds is considered investigational.

Electromagnetic therapy for the treatment of wounds is considered investigational.

Procedure code: E0761, E0769, G0281, G0282, G0295, G0329, 0906T, 0907T

Noncontact ultrasound treatment for wounds

Noncontact ultrasound treatment for wounds is considered investigational, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Procedure code: 97610

Extracorporeal shock wave therapy

The use of extracorporeal shock wave therapy is considered investigational as a treatment for wounds, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Procedure codes: 0512T, 0513T

Noncontact radiant heat bandage

The use of a noncontact radiant heat bandage is considered investigational as a treatment of wounds, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Procedure codes: A6000, E0231, E0232

Ablative laser treatment

The use of ablative laser treatment is considered investigational as a treatment for wounds, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Procedure code: 17999

Near infrared spectroscopy

The use of near-infrared spectroscopy is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Procedure codes: 0640T, 0859T, 0860T, 0972T

Transcutaneous visible light hyperspectral imaging

The use of transcutaneous visible light hyperspectral imaging is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Procedure code: 17999

Directrices de la política

Conventional wound care includes optimization of nutritional status, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, and necessary treatment to resolve any infection that may be present. Conventional wound care based on the specific type of wound includes frequent repositioning of a patient with pressure ulcers (usually every 2 hours), offloading of pressure and good glucose control for diabetic ulcers, establishment of adequate circulation for arterial ulcers, and the use of a compression system for patients with venous ulcers.

Measurable signs of improved healing include a decrease in wound size either in surface area or volume, decrease in amount of exudates, and decrease in amount of necrotic tissue.

Cross-references:

• MP 1.094 Skin Contact Monochromatic Infrared Energy for the Treatment of Cutaneous Ulcers, Diabetic Neuropathy, and Other Miscellaneous Musculoskeletal Conditions
• MP 2.033 Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Non-Orthopedic Conditions
• MP 2.070 Hyperbaric Oxygen Therapy (HBO)
• MP 4.004 Negative Pressure Wound Therapy in the Outpatient Setting
• MP 6.023 Durable Medical Equipment (DME) and Supplies
• MP 8.001 Physical Medicine and Specialized Physical Medicine Treatments (Outpatient)

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

This policy discussion of wound care includes burns, which are considered a type of wound. Wound care involves evaluation and treatment of a wound including identifying potential causes of delayed wound healing and modifying treatment as directed by the certifying physician.

Determining the agent of delayed wound healing such as vascular disease, infection, diabetes or other metabolic disorders, immunosuppression, unrelieved pressure, radiation injury, and malnutrition will help determine the course of treatment. Evaluations could include comprehensive medical evaluation, vascular evaluation, orthopedic evaluation, and metabolic/nutritional evaluation leading to a plan of care.

The plan may include metabolic corrections including dietary supplementation, specialized wound care, pressure relief, use of compression to manage edema, debridement and reconstruction, rehabilitation therapy, possible general, vascular and/or orthopedic surgery, and antimicrobial agents.

Referral to a wound care center would be most appropriate for those wounds that require advanced wound care techniques. Referral to a wound care center is not required for uncomplicated wounds, particularly traumatic wounds, incisions, ischemia, poor nutrition, venous insufficiency, among others.

Referral is also impacted by the complexity of the wound (size, depth, infection, underlying exposed tissues), the chronic (or predicted chronic) duration of the wound, its progress toward healing in the primary caregiver’s hands, and even the location of the wound (wounds on weight-bearing surfaces, those in the head and neck, those on the hands, and other locations require special consideration).

Wound care centers are available to treat complicated wounds, but in many communities the experience, training, judgment, skill, and background to treat complex wounds also exists among vascular, general, plastic, orthopedic and other surgeons, dermatologists, podiatrists, or primary care physicians.

Wound care centers generally do not perform extensive surgical services, which may be required for optimal care. Such procedures may include debridement (minor debridement in the wound care center is appropriate), bypass or other vascular repair, plastic surgical reconstructions, flaps, amputations, and other procedures. Early surgical consultation for such procedures should be sought and the wound care center should not simply continue with more conservative measures when surgical treatment is necessary.

There are some wounds which prove to be essentially chronic, and with which the patient will live indefinitely.

Active wound care management procedures

Active wound care procedures are performed to remove devitalized tissue and promote healing and involve selective and non-selective debridement techniques.

Wound care selective debridement

Debridement is usually indicated whenever necrotic tissue is present on an open wound and may be indicated in cases of abnormal wound healing or repair. Debridement techniques usually progress from non-selective to selective but can be combined. Selective debridement should only be done under the specific order of a physician. Wound care selective treatments include:

• Conservative sharp debridement: Conservative sharp debridement is the classical method of selective wound debridement. Scalpel, curettes, scissors, and tweezers/forceps may be used and only clearly identified devitalized tissue is removed. Conservative sharp debridement is a minor procedure that typically requires no anesthesia and generally results in no bleeding.
• High pressure water jet: Whirlpool provides a means where a wound can be submerged in water and, if appropriate, an additive agent is used for cleansing. Generally, whirlpool treatments do not require the skills of a physical therapist to perform, although a therapist may be required for an accurate assessment of the medical necessity of the whirlpool for the specific wound type. The skills, knowledge, and judgment of a qualified physical therapist might be required when the patient’s condition is complicated by circulatory deficiency, areas of desensitization, complex open wounds, and fractures. Immersion in the whirlpool to facilitate removal of a dressing would not be considered a skilled treatment modality.
• Lavage (non-immersion hydrotherapy): Lavage involves the use of an irrigation device, with or without pulsation, to provide a water jet to administer a shearing effect to loosen debris within a wound. Some electric pulsatile irrigation devices include suction to remove debris from the wound after it is irrigated. This does not include the Ultrasonic Wound Therapy System (MIST) system (see below).

Wound care non-selective debridement

These treatments include the following:

• Blunt debridement: Blunt debridement is the removal of necrotic tissue by cleansing, scraping, chemical application or wet to dry dressing technique. It may also involve the cleaning and dressing of small or superficial lesions. Generally, this is not a skilled service and does not require the skills of a physician, podiatrist, therapist, or wound care nurse.
• Enzymatic debridement: Debridement with topical enzymes is used when the necrotic substances to be removed from a wound are protein, fiber, and collagen. The manufacturers’ product insert contains indications, contraindications, precautions, dosage, and administration guidelines, and it is the clinician’s responsibility to comply with those guidelines.
• Autolytic debridement: This type of debridement is indicated where manageable amounts of necrotic tissue are present, and there is no infection. Autolytic debridement occurs when the enzymes that are naturally found in wound fluids are sequestered under synthetic dressings; it is contraindicated for infected wounds.
• Mechanical debridement: Wet-to-dry dressings may be used with wounds that have a high percentage of necrotic tissue. Wet-to-dry dressings should be used cautiously as maceration of surrounding tissue may hinder healing.
• Jet hydrotherapy and wound irrigation: Mechanical debridement is used to remove necrotic tissue. They also should be used cautiously as maceration of surrounding tissue may hinder healing. Documentation must support the use of skilled personnel in order to be considered a skilled service.

Ultrasound treatment for wounds

Ultrasound (US) delivers mechanical vibration above the upper threshold of human hearing (>20 kHz). US in the megahertz range (1-3 MHz) has been used to treat musculoskeletal disorders, often by physical therapists. Although the exact mechanism underlying its clinical effects is not known, therapeutic US has been shown to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor, collagen production, and increases in macrophage responsiveness, fibrolysis, and nitric oxide levels. The therapeutic effects of US energy in the kilohertz range have also been examined. Although the precise effects are not known, the low-frequency US in this range may improve wound healing via the production, vibration, and movement of micron-sized bubbles in the coupling medium and tissue.

The mechanical energy from the US is typically transmitted to the tissue through a coupling gel. Several high-intensity US devices with contact probes are currently available for wound debridement. Low-intensity US devices have been developed that do not require coupling gel or other direct contact. The MIST Therapy System delivers a saline mist to the wound with low-frequency US (40 kHz). A second device, the Qoustic Wound Therapy System, also uses sterile saline to deliver US energy (35 kHz) for wound debridement and irrigation.

US is intended as an adjunct to standard wound care. Therefore, the evidence is needed that demonstrates US plus standard wound care provides superior wound closure outcomes compared with standard wound care alone.

The primary endpoints of interest for trials of wound closure are as follows, consistent with 2006 guidance from the U.S. Food and Drug Administration (FDA) for the industry in developing products for the treatment of chronic cutaneous ulcers and burn wounds:

• Incidence of complete wound closure.
• Time to complete wound closure (reflecting accelerated wound closure).
• Incidence of complete wound closure following surgical wound closure.
• Pain control.

Regulatory status

In 2005, the MIST Therapy® device (Celleration) was cleared for marketing by the FDA through the 510(k) process "to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria." In February 2015, Celleration was acquired by Alliqua Biomedical (Langhorne, PA). In August 2020, Sanuwave acquired related UltraMIST System assets.

In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical, Minnetonka, MN) was cleared for marketing by the FDA through the 510(k) process, listing the MIST Therapy® system and several other ultrasonic wound debridement and hydrosurgery systems as predicate devices. The AR1000 system probes use contact or noncontact techniques to achieve intended wound therapy modalities "to promote wound healing." Indications in the 510(k) summary are listed as "selective and non-selective dissection and fragmentation of soft and hard tissue" and "surgical excisional or sharp edge wound debridement (acute and chronic wounds, burns) of the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter." This device is now known as the Qoustic Wound Therapy System™.

Several other devices have been approved as being substantially equivalent to the earlier devices. FDA product code: NRB.

Electrostimulation and electromagnetic therapy for the treatment of wounds

Standard treatment

Conventional or standard therapy for chronic wounds involves local wound care, as well as systemic measures including debridement of necrotic tissues, wound cleansing, and dressing that promotes a moist wound environment, antibiotics to control infection, and optimization of nutritional supplementation. Avoidance of weight-bearing is another important component of wound management.

Electrostimulation

Since the 1950s, investigators have used electrostimulation to promote wound healing, based on the theory that electrostimulation may:

• Increase adenosine 5′-triphosphate concentration in the skin
• Increase DNA synthesis
• Attract epithelial cells and fibroblasts to wound sites
• Accelerate the recovery of damaged neural tissue
• Reduce edema
• Increase blood flow
• Inhibit pathogenesis

Electrostimulation refers to the application of electrical current through electrodes placed directly on the skin near the wound. The types of electrostimulation and devices can be categorized into groups based on the type of current. This includes low-intensity direct current, high-voltage pulsed current, and alternating current.

Electromagnetic therapy

Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields, rather than direct electrical current.

Regulatory status

No electrostimulation or electromagnetic therapy devices have received approval from the FDA specifically for the treatment of wound healing. A number of devices have been cleared for marketing for other indications. Use of these devices for wound healing is off label.

Noncontact radiant heat bandage

The optimal environment for wound healing is thought to include a moist warm environment. Warm-Up Active Wound Therapy™ is a device approved by the FDA that attempts to create this environment. The device includes a noncontact bandage and a warming unit. Treatments are typically administered three times per day for one hour per session.

Extracorporeal shock wave therapy

Extracorporeal shock wave therapy (ESWT) was originally used for stone management in urology and was subsequently introduced as treatment for various musculoskeletal disorders. Today, the application of ESWT has been expanded to new therapeutic fields including wound healing and has offered a potential solution for improving the wound-healing process.

Ablative laser treatment

Ablative fractional lasers have recently been employed for the treatment of hypertrophic and function-limiting scars. This therapy has been shown to induce healing of chronic wounds in patients with persistent ulcers and erosions with traumatic scars. Recent reports suggest it may be applicable to other types of chronic wounds as well. The mechanism of action for this modality has yet to be discovered but possible factors include laser-induced collagen remodeling, photomicrodebridement and disruption of biofilms, and induction of a proper wound healing cascade.

Near infrared spectroscopy

Near infrared spectroscopy (NIRS) is a noninvasive modality that measures maximum light absorption wavelengths of different components, including oxygen saturation, hemoglobin content, and water content, around wound sites. NIR imaging can also be used to estimate the depth of burn wounds. In addition, it has been utilized to monitor the wound healing process. However, due to the potential overlap/shifting of the absorption wavelengths of various components, NIRS can sometimes lack specificity.

Transcutaneous visible light hyperspectral imaging

HyperMed Imaging's product, HyperView™, is a handheld, battery-operated, portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient. The product is intended for use by physicians and healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of oxygen saturation (O2Sat), oxyhemoglobin level (Oxy), and deoxyhemoglobin level (Deoxy) in superficial tissue. The HyperView system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface. Images and data provide hyperspectral tissue oxygenation measurements for selected tissue regions. The product is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise, such as wound healing, diabetic foot ulcers, amputation, and critical limb ischemia.

Regulatory status

The HyperView™ system was cleared via the FDA's 510(k) process on December 16, 2016. Product code: MUD.

Fundamento

Ultrasound treatment for wounds: Summary of evidence

For individuals who have any wound type (acute or nonhealing) who receive ultrasound therapy plus standard wound care, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The single double-blinded, sham-controlled randomized trial, which included patients with nonhealing diabetic foot ulcers, had substantial methodologic flaws (e.g., high dropout rate, baseline differences between groups) that limit the validity of the findings. In the remaining studies comprising the evidence base, all but one RCT comparing noncontact low-frequency ultrasound (NLFU) with standard wound care reported improved (statistically significant) results on the primary outcome with NLFU. However, these studies also had several methodologic limitations. Complete healing is the most clinically relevant outcome. None of the RCTs evaluating venous leg ulcers reported complete healing as its primary outcome measure, and none had blinded outcome assessment. Only one RCT, which addressed split-thickness graft donor sites, reported on the proportion of patients with complete healing and had blinded outcome assessment. Another limitation of the body of evidence is that some standard of care interventions involved fewer visits than the NLFU intervention, and the differences in intensity of care resulting from this differential in face-to-face contact could partially explain the difference in findings between intervention and control groups. The evidence is insufficient to determine the effects of the technology on health outcomes.

Electrostimulation and electromagnetic therapy for treating wounds: Summary of evidence

For individuals who have any wound type (acute or nonhealing) who receive electrostimulation, the evidence includes systematic reviews, meta-analyses, and RCTs. Relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. Systematic reviews of RCTs on electrical stimulation have reported improvements in some outcomes, mainly intermediate outcomes such as a decrease in wound size and/or the velocity of wound healing. There are few analyses on the more important clinical outcomes of complete healing and the time to complete healing, and many of the trials are of relatively low quality. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have any wound type (acute or nonhealing) who receive electromagnetic therapy, the evidence includes systematic reviews of RCTs (one on pressure ulcers and the other on leg ulcers) and an RCT on electromagnetic treatment of diabetic foot ulcers. Relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. The systematic reviews identified a few RCTs with small sample sizes that do not permit drawing definitive conclusions. The evidence is insufficient to determine the effects of the technology on health outcomes.

Noncontact radiant heat bandage for the treatment of wounds: Summary of evidence

Standard components of wound care include sharp debridement of devitalized tissue, infection control, non-weight bearing, and treatment of underlying comorbidities, such as adequate nutrition or glycemic control in diabetics. Therefore, validation of any adjunct to standard wound management to isolate the contribution of the intervention compared to underlying management is required. A literature review identified one small, randomized crossover trial of warm-up active wound therapy involving fifteen patients who were followed up for two weeks. Compared to the control group, more patients in the treatment group improved (62.5% vs. 37.5%). However, the term "improvement" was not fully defined, and no statistical analysis was provided. Santilli and colleagues reported a two-week trial of warm-up active wound therapy in which seven patients with thirty-one wounds served as their own control. Almost half of these patients, all refractory to prior therapy, reported complete healing within twelve weeks after treatment. While studies of wound-healing therapies frequently use patients as their own control, this trial design cannot isolate the contribution of the intervention from the underlying wound care rather than the warm-up active wound therapy itself. Finally, Cherry and Wilson reported a case series of five patients who received a two-week trial of warm-up active wound therapy. Although four of the five patients reported complete healing at six to fourteen weeks after treatment, again, a case series does not permit isolation of the contribution of the warm-up therapy. In addition, both in this trial and in the previous trial reviewed, it should be noted that wound healing occurred several weeks after discontinuation of the warm-up therapy, further confounding any evaluation of the therapy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Extracorporeal shock wave therapy: Summary of evidence

For individuals who have any wound type who receive extracorporeal shock wave therapy plus standard wound care, the evidence includes RCTs and systematic reviews. ESWT showed therapeutic effects on acute and chronic soft tissue wound of different etiologies. However, the effectiveness of ESWT still requires further high-quality, well-controlled RCTs with an adequate sample size because the existing clinical and experimental evidence has been limited. Furthermore, optimal ESWT regimens and dosages are required to provide evidence-based therapeutic guidance. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ablative laser treatment

There are limited studies, and overall effectiveness cannot be demonstrated. Larger, randomized, and controlled trials will need to be conducted to best determine appropriate treatment protocols. The evidence is insufficient to determine the effects of the technology on health outcomes.

Near infrared spectroscopy

There are limited studies and overall small sample sizes on this imaging and overall effectiveness cannot be demonstrated. The evidence is insufficient to determine the effects of the technology on health outcomes.

Transcutaneous visible light hyperspectral imaging

There are limited studies and proven efficacy on this imaging and overall effectiveness cannot be demonstrated. The evidence is insufficient to determine the effects of the technology on health outcomes.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Noncontact ultrasound treatment for wounds is investigational; therefore, not covered:

Extracorporeal shock wave therapy is investigational; therefore, not covered:

Electrostimulation for wounds, electrostimulation for home use, and electromagnetic therapy for the treatment of wounds is investigational; therefore, not covered:

Noncontact radiant heat bandage is investigational; therefore, not covered:

Ablative laser treatment is investigational; therefore, not covered:

Near-infrared spectroscopy is investigational; therefore, not covered:

Transcutaneous visible light hyperspectral imaging is investigational; therefore, not covered:

Covered when medically necessary:

*Appropriate ICD-10 codes for specialized wound or burn care could potentially involve any wound or burn diagnosis.

Referencias

1. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment. Rockville, MD: Food and Drug Administration; 2006 June.
2. Food and Drug Administration. MIST Therapy System: 510(k) Premarket Notification: K050129.
3. Food and Drug Administration. 510(k) Summary: 510(k) – AR1000 Series K131096, Arobella Medical, LLC. 2014.
4. Tricco AC, Antony J, Vafaei A, et al. Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Med. Apr 22, 2015; 13: 89. PMID 25899006
5. Voigt J, Wendelken M, Driver V, et al. Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials. Int J Low Extrem Wounds. Dec 2011; 10(4): 190-9. PMID 22184750
6. Ennis WJ, Foreman P, Mozen N, et al. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. Aug 2005; 51(8): 24-39. PMID 16234574
7. Peschen M, Weichenthal M, Schopf E, et al. Low-frequency ultrasound treatment of chronic venous leg ulcers in an outpatient therapy. Acta Derm Venereol. Jul 1997; 77(4): 311-4. PMID 9228227
8. Chang JR, Perry J, Cross K. Low-frequency ultrasound debridement in chronic wound healing: a systematic review of current evidence. Plast Surg (Oakv). Feb 2017; 25(1): 21-26. PMID 29026808
9. Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: Mayo Clinic experience, 2004-2006. Adv Skin Wound Care. Apr 2007; 20(4): 221-6. PMID 17415030
10. Beheshti A, Shafigh Y, Parsa H, et al. Comparison of high-frequency and MIST ultrasound therapy for the healing of venous leg ulcers. Adv Clin Exp Med. Nov-Dec 2014; 23(6): 969-75. PMID 25618125
11. Olyaie M, Rad FS, Elahifar MA, et al. High-frequency and noncontact low-frequency ultrasound therapy for venous leg ulcer treatment: a randomized, controlled study. Ostomy Wound Manage. Aug 2013; 59(8): 14-20. PMID 23934374
12. White J, Ivins N, Wilkes A, et al. Non-contact low-frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single-centre, assessor-blinded, randomised controlled trial. Int Wound J. Octubre de 2016; 13(5): 833-42. PMID 25619411
13. Gibbons GW, Orgill DP, Serena TE, et al. A prospective, randomized, controlled trial comparing the effects of noncontact, low-frequency ultrasound to standard care in healing venous leg ulcers. Ostomy Wound Manage. Jan 2015; 61(1): 16-29. PMID 25581604
14. Prather JL, Tummel KE, Patel AB, et al. Prospective randomized controlled trial comparing the effects of noncontact low-frequency ultrasound with standard care in healing split-thickness donor sites. J Am Coll Surg. Aug 2015; 221(2): 309-18. PMID 25868409
15. Gottrup F, Apelqvist J, Price P. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. Jun 2010; 19(6): 237-68. PMID 20551864
16. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. 2010.
17. Association for the Advancement of Wound Care (AAWC). International Consolidated Venous Ulcer Guideline (ICVUG) 2015 (Update of AAWC Venous Ulcer Guideline, 2005 and 2010). 2015.
18. O'Donnell TF, Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. Aug 2014; 60(2 Suppl): 3S-59S. PMID 24974070
19. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: a clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. Febrero de 2016; 63(2 Suppl): 3S-21S. PMID 26804367

Ultrasound treatment for wounds

1. Barnes R, Shahin Y, Gohil R, et al. Electrical stimulation vs. standard care for chronic ulcer healing: a systematic review and meta-analysis of randomised controlled trials. Eur J Clin Invest. Apr 2014; 44(4): 429-40. PMID 24456185
2. Franek A, Kostur R, Polak A, et al. Using high-voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized, controlled clinical study. Ostomy Wound Manage. Mar 2012; 58(3): 30-44. PMID 22391955
3. Houghton PE, Campbell KE, Fraser CH, et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil. May 2010; 91(5): 669-78. PMID 20434602
4. Kawasaki L, Mushahwar VK, Ho C, et al. The mechanisms and evidence of efficacy of electrical stimulation for healing of pressure ulcer: a systematic review. Wound Repair Regen. Mar-Apr 2014; 22(2): 161-73. PMID 24372691
5. Lala D, Spaulding SJ, Burke SM, et al. Electrical stimulation therapy for the treatment of pressure ulcers in individuals with spinal cord injury: a systematic review and meta-analysis. Int Wound J. Diciembre de 2016; 13(6): 1214-1226. PMID 25869151
6. Liu LQ, Moody J, Traylor M, et al. A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries. J Spinal Cord Med. Nov 2014; 37(6): 703-18. PMID 24969965
7. Thakral G, LaFontaine J, Kim P, et al. Treatment options for venous leg ulcers: effectiveness of vascular surgery, bioengineered tissue, and electrical stimulation. Adv Skin Wound Care. Apr 2015; 28(4): 164-72. PMID 25775200
8. Arora M, Harvey LA, Glinsky JV, et al. Electrical stimulation for treating pressure ulcers. Cochrane Database Syst Rev. Jan 22, 2020; (1): CD012790. PMID 31962369
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