NCT07172893

A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL

A Non-Randomized Open Label Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of DermaBind TL, a Placental Membrane Allograft Intended for Use in the Management of Non-Healing Ulcers

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: HealthTech Wound Care · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic non-healing ulcers.

Detailed description

This clinical trial will assess the effectiveness of HealthTech Wound Care's medical intervention with the use of DermaBind TL™. HealthTech Wound Care will analyze data related to specific endpoints, such as, wound area preservation over time, rate of wound infection over time, rate of wound reoccurrence post-treatment through EOS, the average number of grafts used per subject and incidence of treatment-emergent adverse events. The goal is to determine whether the intervention produces the desired effects. HealthTech Wound Care will use each study subject's historical data in relation to existing treatments when summarizing data. This study is a prospective, multi-center, open-label, single arm clinical trial designed to collect patient outcome data on commercially available dressing/covering for the protection of DFUs or VLUs over a 12-week treatment period. Wound assessment will be conducted by a clinician, Principal Investigator/Sub-Investigator at each site. The study will include adult patients with chronic non-healing wounds that have failed to respond to standard or conservative treatments. These wounds may include diabetic foot ulcers and venous leg ulcers. The treatment period will be 12 weeks, during which DermaBind TL™ will be applied to the affected wound. The study will monitor outcomes related to , wound area protection, infection rates, through EOS, and adverse events. The study involves two phases: Screening and Treatment

Conditions

• Diabetic Foot Ulcer (DFU)
• Venous Leg Ulcer (VLU)

Interventions

Type	Name	Description
BIOLOGICAL	DermaBind TL	Full-Thickness Dehydrated Placental Allograft

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-02-21
• Completion: 2027-05-21
• First posted: 2025-09-15
• Last updated: 2025-12-23

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study