Diabetic foot ulcers (DFUs) may affect up to 25% of people with diabetes at some point in their lifetime. Once a person has developed a DFU, there is a 50% chance the ulcer will become infected. DFUs are also among the leading causes of amputation.
By the WoundSource Editors
When determining the course of action for treating a given wound, it is important that wound care clinicians evaluate how advanced wound care therapies have been deemed evidence based and how the specific product technology works. Evidence-based advanced wound care products are required to be safe and effective based on epidemiology, etiology, and pathophysiology. However, safety and efficiency are not a 100% guarantee of effectiveness in clinical practice.
The Role of the FDA in Wound Care Technology
Safety is the foundation of any health care activity or intervention, so it can be deemed effective. The US Food and Drug Administration (FDA) guidance document for treatment of chronic wounds and burn wounds explains that wound care products should provide patient benefits while improving wound care relative to standard care, and products should not significantly impede healing. Manufacturers must closely monitor reports of product-related safety problems because the FDA mandates reports from both the health care provider and the manufacturer to monitor rates of adverse events. Effectiveness consists of selecting the best treatment when caring for a chronic wound patient while using current best evidence. Knowledge of physical wound characteristics, local and systemic factors, and patients’ preferences for treatment are also required. This process is not only lengthy and expensive, but it also presents potential regulatory concerns and reimbursement issues.
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Understanding Study Designs
Product and device classifications are grouped based on common materials, composition, and functional performance characteristics. Therefore, the products may not function alike even though they are placed in the same category. Health care professionals and researchers should evaluate and analyze results using various study designs that predict effectiveness. Poorly designed cohort, case, and multiple case series studies make it a challenge for health care clinicians to make evidence-based decisions.1
- Comparison cohort and/or observational studies summarize daily clinical practice. This study design compares alternative treatment approaches rather than comparing treatment outcomes with a placebo or sham devices. The pros are that the study reflects a “real-world” setting, and it is less expensive. Cons are confounding variables, as well as reliability and validation of data sources.2,3
- Retrospective studies compare treatment approaches that are documented in a large patient database. However, inclusion of patients who are transferred between health care settings and treated with various interventions leads to inaccurate and incomplete results.2
- Case studies and multiple case series provide valuable information, but evidence is limited from a safety and efficacy standpoint. Clinical trials have both pros and cons within this study style. The pro is minimizing confounding variables. The cons are that these studies are expensive, not always feasible, and not reflective of “real-world” settings.2,3
- Systematic reviews of evidence include data from a variety of study designs, patient-centered outcomes, and appropriate treatment, leading to strong evidence.2
When selecting and evaluating elements of evidence-based dressings, clinicians should focus on the characteristics and function of the dressing.2 Dressings that are placed within the same category many have different functions, depending on the specific product technology utilized. Some common dressing features to evaluate include whether the dressing:
- Creates an optimal moist environment
- Donates moisture if the wound is dry or desiccated
- Provides thermoregulation to the wound bed
- Provides an effective bacterial barrier
- Absorbs or wicks away excess exudates
- Provides periwound area protection
- Conforms to wound shape and location
- Allows for easy application and removal
- Utilizes non-cytotoxic materials
- Includes an appropriate antimicrobial or antibacterial agent as indicated
Advanced wound care therapy guideline foundations are based on safety and effectiveness. However, evidence-based research continues to be lacking in the wound care arena. Ongoing debates on research layouts between clinicians and manufacturers are exploring other options and designs to streamline safety and effectiveness. Clinicians should carefully evaluate dressing materials and categories when deciding what advanced wound care therapy dressings to use or recommend.
1. van Rijswijk L, Gray M. Evidence, research, and clinical practice: a patient-centered framework for progress in wound care. Ostomy Wound Manage. 2011;57(9):26-38.
2. Sood A, Granick MS, Tomaselli NL. Wound dressings and comparative effectiveness data. Adv Wound Care (New Rochelle). 2014;3(8):511-529. doi:10.1089/wound.2012.0401.
3. Gilligan AM. Health economics and outcomes research of wound care: overview of methodology. Adv Wound Care (New Rochelle). 2018;7(11):380-386. doi:10.1089/wound.2018.0817.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.