Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.

Part of paid clinical trials in Monroe, North Carolina.

Sponsor
Samaritan Biologics
Study ID
NCT06437028
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dual-layer perinatal tissue allograft — OTHER
    The dual-layer perinatal tissue allograft is an amnion - amnion allograft
  • Three-layer fenestrated perinatal tissue allograft — OTHER
    The three-layer fenestrated perinatal tissue allograft is an amnion - chorion - amnion allograft
  • Standard of care — OTHER
    Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.

Study Details

The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.

Key Dates

Start date
May 9, 2025
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Dual-layer perinatal tissue allograft
    Patients will receive weekly applications of a dual-layer perinatal tissue allograft in addition to standard of care wound management.
  • Experimental: Three-layer fenestrated perinatal tissue allograft
    Patients will receive weekly applications of a three-layer fenestrated perinatal tissue allograft in addition to standard of care wound management.
  • Active Comparator: Standard of care (SOC) wound management
    Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.

Primary Outcome Measure

Incidence of Complete Wound Closure [ Time Frame: 12-weeks following study screening phase ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Monroe Biomedical ResearchMonroeNorth Carolina28112
Krista Gross
[email protected]
704-283-7369
Awawu Igbinadolor, MD (PRINCIPAL_INVESTIGATOR)

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