Outcomes and Predictors of Wound Healing among Patients with Complex Diabetic Foot Wounds Treated with a Dermal Regeneration Template (Integra).

Background: The utility of dermal regeneration templates for treating high-risk diabetic foot wounds is unclear. The authors report wound healing and major amputation outcomes among a cohort of diabetic patients with complex diabetic foot wounds treated in a multidisciplinary setting.

Methods: All patients with complex diabetic foot wounds treated with a dermal regeneration template (March of 2013 to February of 2019) were captured in a prospective institutional database. Wound severity was classified according to the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system to determine limb salvage prognosis at baseline. Wound healing and major amputation rates were reported using Kaplan-Meier analyses. A stepwise Cox proportional hazards model was used to identify independent characteristics associated with wound healing.

Results: Eighty-five patients with 107 complex diabetic foot wounds were treated (mean age, 61.2 ± 3.3 years; 63.5 percent male and 61.2 percent African American). Most diabetic foot wounds were high-risk (wound, ischemia, and foot infection stage 3 or 4, 93.5 percent), corresponding to a predicted 25 to 50 percent risk of major amputation at 1 year. Dermal regeneration template use resulted in successful wound granulation in 66.7 percent of cases, with a mean time to complete wound healing of 198 ± 18 days. Twelve- and 18-month wound healing rates were 79.0 ± 5.0 percent and 93.0 ± 3.3 percent, respectively. Major amputation was required in 11.2 percent of patients. Independent predictors of poor wound healing included lack of bone involvement, higher WIfI stage, and prior dermal regeneration template failure.

Conclusion: Application of a dermal regeneration template to complex diabetic foot wounds at high risk for major amputation results in good wound healing and excellent limb salvage outcomes among diabetic patients treated in a multidisciplinary setting.

Clinical Question/level Of Evidence: Therapeutic, IV.