NCT05883098

SDRM® vs. Collagen for Diabetic Foot Ulcers

Effectiveness of Supra SDRM® vs. Fibracol Plus Collagen in the Treatment of Diabetic Foot Ulcers: a Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Polymedics Innovations Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.

Detailed description

Chronic wounds are those that fail to proceed through the normal phases of wound healing. They pose a high risk for infection and risk complications resulting in amputation. A plethora of wound treatment modalities are commercially available to help improve patient outcomes. However, even when combined with a good standard of care practices and wound dressings, they may not be sufficient to promote timely wound closure. Cellular and/or tissue- based products (CTPs) may provide a healing advantage over traditional dressings. CTPs are derived from human (allograft), animal (xenograft), or synthetic materials or a combination thereof. CTPs can help encourage tissue repair or regeneration by providing scaffolds and the cells necessary to stimulate wound healing. Synthetic products may provide advantages over human or other animal sourced products because they are natural, non-biologic, avoid complications due to risk of disease transmission, and possess less immunologic potential. The fully synthetic skin substitute evaluated in this study is SUPRA SDRM® Synthetic Biodegradable Matrix Wound Dressing (Polymedics Innovations Inc.; Woodstock,GA). The device is a novel synthetic, guided wound closure matrix, built as a bimodal foam membrane structure for the management of chronic wounds. It combines the benefits of a microporous structure that builds a protective barrier allowing the wound to heal and additional large pores which were created to enable ingrowth of blood vessels. This microenvironment initially provides a seal against contamination and modulates inflammation in wound bed. Subsequently, it supports cellular processes required for tissue repair and wound healing. In this parallel randomized clinical trial, patients with diabetic foot ulcers grade UT 1A will receive either standard of care plus SUPRA SDRM or a collagen dressing (Fibracol Plus) weekly after wound debridement. Primary outcomes will be time to achieve wound healing, and the proportion of patients achieving healing by 12 weeks. Secondary outcomes will include the direct costs of treatment and the proportion of patients who developed infections during the trial.

Conditions

• Diabetic Foot
• Ulcer Foot
• Wound Heal

Interventions

Type	Name	Description
PROCEDURE	Wound debridement	The study's wounds will be mechanically debrided before the experimental or active comparator devices are applied. Debridation will be performed by a trained clinician using a curette. Necrotic tissue and slough will be removed during this procedure.
DEVICE	Wound closure matrix application	After wound debridement, the patients will receive the application of a wound closure matrix as dictated by their randomization allocation.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-01-31
• Completion: 2023-06-01
• First posted: 2023-05-31
• Last updated: 2023-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study