NCT05797285

Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers

A Randomized Clinical Pilot Evaluating The Efficacy For Two Application Regimens Of A Unique Keratin Based Graft In The Treatment Of Non-Healing Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: ProgenaCare Global, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to the target wound. Researchers will compare how weekly or bi-weekly application of ProgenaMatrix affects the healing of DFUs. The primary questions to be answered are: 1. How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And 2. What is the change in wound area during the trial in each group?

Detailed description

ProgenaMatrix® is a human keratin graft that is 510K approved for application on diabetic foot wounds and has been shown in case studies and clinical practice to assist in wound healing . Additionally, a study published by Tang and Kirsner showed that keratin stimulates human keratinocyte migration and types IV and VII collagen expression. Therefore, based on this early promising data, a larger pilot is necessary to further validate these results and identify the likelihood of wound healing with weekly versus bi-weekly application. For consistency, one type of wound will be studied in this trial and DFU's have been chosen as they are some of the most common wounds seen in the wound clinics. The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared synthetic, absorbable skin substitute matrix. The commercially available product is ProgenaMatrix® Advanced Wound Graft and consists of Human Keratin Matrix. In this trial, two groups of subjects with diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will be randomized to a 510K FDA cleared ProgenaMatrix® applied weekly and the other half will be randomized to a 510K FDA cleared ProgenaMatrix® applied bi-weekly (i.e., once every two weeks).

Conditions

• Ulcer Healing
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	human keratin graft	The intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies.

Timeline

• Start date: 2023-02-28
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2023-04-04
• Last updated: 2024-02-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study