DermaBind TL for Venous Ulcers

Recruiting at 9 trial locations

Overseen By Doug Schmid Chief Scientific Officer, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: HealthTech Wound Care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Stan Andrews, MS

Principal Investigator

Professional Education and Research Institute

Are You a Good Fit for This Trial?

Adults aged 18-80 with chronic non-healing ulcers, specifically diabetic foot ulcers (DFU) grades 1 or 2. Participants must have stable diabetes treatment for at least 30 days, an A1C ≤10%, a single target ulcer not probing to bone and distant from other wounds, and no infection as confirmed by radiographic evidence.

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.

I have been diagnosed with Type I or Type II diabetes.

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 stable anti-diabetic medication for at least 30 days, or if diet-controlled only, must have been on stable diet-control for at least 6 months.

What Are the Treatments Tested in This Trial?

Interventions

• DermaBind TL

Trial Overview

The trial is testing DermaBind TL™ on patients with chronic non-healing wounds like venous ulcers and diabetic foot. It's an open-label study which means everyone knows they're getting the test product, aiming to assess its effectiveness in healing these types of wounds.

How Is the Trial Designed?

Group I: Efficacy, Safety, and Tolerability of DermaBind TL Experimental Treatment 1 Intervention

The SOC therapy in this study is offloading of the DFU or VLU (Foot Defender® CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM Boot), appropriate sharp or surgical debridement, infection management and wound care covering with dehydrated Placental membrane tissue allograft (DERMABIND TL™), and a non-adherent dressing, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Who Is Running the Clinical Trial?

HealthTech Wound Care

Lead Sponsor