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
HealthTech Wound Care
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.
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 exist…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Be an adult between 18 and 80 years of age at the time of consent 2. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix A for definitions) on the plantar, lateral or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus. 3\. Subjects must have a diagnosis of Type I or Type II diabetes mellitus (DM) as defined by the American Diabetes Association 1. for Type I DM, have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit, or 2. for Type II DM, must have been on a stab…
Interventions
- BiologicalDermaBind TL
Full-Thickness Dehydrated Placental Allograft
Locations (10)
- Midland Florida Clinical Research CenterDeLand, Florida
- Pharmakon Medical ResearchPalm Beach Gardens, Florida
- Vital Medical ResearchSweetwater, Florida
- EMbassy Research NetworkBloomfield Township, Michigan
- US Foot and Ankle Specialists-Cary Satellite SiteCary, North Carolina
- US Foot and Ankle SpecialistsRaleigh, North Carolina