A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL

Part of paid clinical trials in DeLand, Florida.

Sponsor
HealthTech Wound Care
Study ID
NCT07172893
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • DermaBind TL — BIOLOGICAL
    Full-Thickness Dehydrated Placental Allograft

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Dec 2025
Primary completion
Feb 21, 2027
Completion
May 21, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Efficacy, Safety, and Tolerability of DermaBind TL
    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).

Primary Outcome Measure

Measure the protective effect of the wound covering on the wound over the 13-week treatment period [ Time Frame: 13 weeks ]

Central Contacts

  • Doug Schmid Chief Scientific Officer, PhD
    801-556-9799
    [email protected]
  • Jessica Study Coordinator, NP-C, WCC
    231-651-0592

Locations (10)

FacilityCityStateZIPSite coordinators
Midland Florida Clinical Research CenterDeLandFlorida32720-
Pharmakon Medical ResearchPalm Beach GardensFlorida33410-
Vital Medical ResearchSweetwaterFlorida33174-
EMbassy Research NetworkBloomfield TownshipMichigan48302-
US Foot and Ankle Specialists-Cary Satellite SiteCaryNorth Carolina27518-
US Foot and Ankle SpecialistsRaleighNorth Carolina27609-
US Foot and Ankle SpecialistsBlue AshOhio45242-
Lower Extremity Institute for Research and TherapyBoardmanOhio44512-
Perfizien Clinical Research, LLC.HoustonTexas77055-
Foot and Ankle Specialists of the Mid-AtlanticSalemVirginia24153-

Find similar trials in DeLand, FL

By research site
Midland Florida Clinical Research Center· DeLand, FLPharmakon Medical Research· Palm Beach Gardens, FLVital Medical Research· Sweetwater, FLEMbassy Research Network· Bloomfield Township, MIUS Foot and Ankle Specialists-Cary Satellite Site· Cary, NCUS Foot and Ankle Specialists· Raleigh, NC

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