Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05883098
Study type Interventional
Source Polymedics Innovations Inc.
Contact
Status Completed
Phase N/A
Start date July 1, 2022
Completion date June 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06154915 - Immune Cells in Diabetic Chronic Foot Ulcers
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Not yet recruiting NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Completed NCT02373592 - Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer N/A
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01212120 - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections N/A
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Recruiting NCT04085705 - The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Completed NCT04480801 - The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer N/A
Not yet recruiting NCT04537676 - Patient Empowerment Study
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A
Recruiting NCT05974592 - The Effect of Nurse-Led Diabetic Foot Self-Management Training Program N/A
Not yet recruiting NCT04630795 - ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
Not yet recruiting NCT05431660 - Diabetic Foot School and Biomechanics N/A
Completed NCT05101473 - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study N/A
Completed NCT05123157 - Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT03254095 - Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.