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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05883098
Other study ID # PMI-SUPRASDRM®-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date June 1, 2023

Study information

Verified date August 2023
Source Polymedics Innovations Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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 SDRMĀ® 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 1, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males and females aged 18 or older. - Subject is willing to sign an informed consent and participate in all procedures and follow-up evaluations. - Study ulcer is diabetic in origin, located on foot or below the malleolus (UT Grade 1A). - Study ulcer size is a minimum of 2 cm2 and a maximum of 25 cm2. - Study ulcer has been present for a minimum of 4 weeks before enrollment and less than 1 year old. - Study ulcer has been offloaded for at least 14 days before randomization. - Subject does not exhibit clinical signs or symptoms of infection. - Subject has adequate control of diabetes demonstrated by Hemoglobin A1c < 12% within 90 days of screening. - Subject has adequate circulation to the affected extremity. Exclusion Criteria: - Study ulcer has > 40% wound healing during the 14 days screening period. - Subject has a known history of poor compliance with medical treatments. - Subject is presently participating in another clinical trial. - Subject has a known or suspected local or systemic malignancy. - Subject has been diagnosed with autoimmune connective tissues diseases. - Subject has received graft material or topical growth factors on the study ulcer within the previous 30 days. - Subject has received application of topical steroids on the study ulcer surface within the previous 30 days. - Subject is pregnant or breast feeding. - Subject is on dialysis. - Subject is taking medications that are considered immune system modulators or cytotoxic chemotherapies. - Subject cannot be on systemic antibiotics prior to randomization, however, during the treatment phase infection management may include systemic antibiotics if in conjunction with debridement. - Subject has a known allergy to ingredients/components of Supra SDRMĀ®. - Subject has osteomyelitis, and/or bony prominences present in the wound. - Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D). - Subject is unable to comply with planned study procedures and treatments.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States WAFL Inc Circleville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Polymedics Innovations Inc. McGill University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635. — View Citation

Haller HL, Sander F, Popp D, Rapp M, Hartmann B, Demircan M, Nischwitz SP, Kamolz LP. Oxygen, pH, Lactate, and Metabolism-How Old Knowledge and New Insights Might Be Combined for New Wound Treatment. Medicina (Kaunas). 2021 Nov 1;57(11):1190. doi: 10.3390/medicina57111190. — View Citation

Mirhaj M, Labbaf S, Tavakoli M, Seifalian AM. Emerging treatment strategies in wound care. Int Wound J. 2022 Nov;19(7):1934-1954. doi: 10.1111/iwj.13786. Epub 2022 Mar 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to heal Number of weeks required to achieve 100% epithelization of the wound Up to 30 weeks
Primary Healing by 12 weeks Proportion of patients achieving 100% epithelization on or before week 12 12 weeks
Secondary Direct costs Direct costs of treatment Up to 30 weeks
Secondary Infection rate Proportion of patients developing an infection in the wound bed Up to 30 weeks
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