HealthTech Wound Care
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.
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…
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…
Full-Thickness Dehydrated Placental Allograft