Devices for Local Treatment of Chronic Wounds

Purpose and Scope of the EGD 

The purpose of this EGD is to provide recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for devices intended for local treatment of chronic wounds.  This EGD is relevant to chronic wounds including venous stasis ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds.

Devices addressed by the recommendations in this EGD include, but are not necessarily limited to, negative pressure wound therapy (NPWT), electrotherapy and electromagnetic therapy, pulsed monochromatic light therapy, low level light laser therapy, low energy ultrasound therapy, and topical oxygen therapy (Cullum et al., 2001; Enoch et al., 2006; Leach et al., 2006; Bishop, 2008; Jull et al., 2008; Reddy et al., 2008; Ubbink et al., 2008) *.  Topical therapies, biological agents, and systemic therapies are outside the scope of this EGD, and the study design recommendations discussed below were not developed with the intent of informing trial design for these types of interventions.

Throughout the EGD we use the definition for a chronic wound as one “that has failed to proceed through an orderly and timely series of events to produce a durable, structural and cosmetic closure” (Bradley et al., 1999).  Chronic wounds may also be defined in terms of chronicity - that is, a wound that fails to respond to standard therapy within 30 days or has not resulted in the expected improved functional outcome (NPWT: Technology Assessment, 2009).

The EGD recommendations are intended to reflect the type of evidence that would be useful to patients, clinicians, guideline developers, payers and other “post-regulatory” decision makers in making health care decisions at the individual and population level.  The objective is to describe features of study design, implementation and reporting that would provide these decision makers with a reasonable level of confidence that the technology improves health outcomes.  The relative importance and weight assigned to each recommendation is characterized as “important”, “strongly preferred” or “preferred”.  Different decision makers may weigh these individual characteristics of studies differently, and the EGD attempts to integrate input from the full range of potential decision makers.   The recommendations are not intended to comprehensively address every potential aspect of trial design, and should not be used as a all-inclusive “recipe” for protocol development.  Because each recommendation in the EGD reflects the views of at least one important category of decision makers, it will be useful for clinical researchers and product developers to have a clear rationale for designing studies that deviate from these recommendations.   Finally, because the EGD recommendations reflect what would produce a “reasonable level of confidence” for decision makers, it will generally be the case that additional clinical research will almost always be useful.

Providing Comments on the EGD

As with all CMTP Guidance Documents, your feedback is critical to ensuring the document reflects the best thinking on the design of chronic wound treatment studies. To make the process of providing comments as easy as possible, we have set up an online questionnaire that captures your overall opinion of the EGD, and offers space for you to provide specific changes to the wording and structure of the EGD. By using this form, we will be able to more rapidly include your recommendations into the final document.

 * Please refer to the document for a full list of the citations.

Documents

• Devices for Local Treatment of Chronic Wounds Effectiveness Guidance Document (version 1.0).  Published September, 2009.
• NPWT Working Group