What is this study studying for diabetic foot ulcers?

This study is evaluating three types of placental tissue allografts combined with standard wound care to see if they improve healing of chronic diabetic foot ulcers compared to standard care alone. The research aims to find better treatments for these difficult-to-heal wounds. The study is sponsored by Tides Medical.

Who may be eligible for this diabetic foot ulcer clinical trial?

Adults aged 18 years or older with a diabetic foot ulcer that has lasted more than 4 weeks but less than 1 year may be eligible. The ulcer must be below the ankle and meet blood flow and size requirements. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetic foot ulcer clinical trial?

Study-related care, including the study treatments and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06681428

Study Comparing Amniotic Membrane Allografts and Standard Care for Treating Chronic Diabetic Foot Ulcers

Led by Tides Medical · Updated on 2025-02-10

240

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of three types of placental tissue allograftsAmnionChorionAmnion, AmnionChorion, and AmnionAmnionalongside standard wound care compared to standard care alone for treating chronic non-healing diabetic foot ulcers DFUs. The study focuses on adults with chronic DFUs to understand whether adding these allografts improves healing after 12 weeks of treatment. Participants will receive one of several treatments topical application of a tri-layer dehydrated amniotic membrane allograft, a tri-layer amnionchorion allograft, a dual-layer amnionamniotic membrane allograft, or standard wound care alone. Standard care includes calcium alginate dressings, padded multi-layer dressings, offloading boots or total contact casting, debridement, and infection management. The allografts provide a protective cover and support the bodys natural healing processes and are applied directly to the ulcer without removal. During the study, participants will attend weekly visits for up to 12 weeks. Researchers will assess wound healing by measuring the percentage of ulcers healed, total time to wound closure, reduction in wound size over time, and changes in patients reported wound pain. The study includes careful monitoring of ulcer condition and overall health to evaluate treatment safety and effectiveness over the treatment period.

CONDITIONS

Brief Title

Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

At least 18 years old
Presence of a diabetic foot ulcer (DFU), Wagner Grade 1, extending through the dermis and located below the medial malleolus
The largest ulcer will be selected if multiple DFUs of the same grade exist, with other ulcers on the same foot more than 2 cm away
Ulcer present for more than 4 weeks but less than 1 year before consent
Ulcer size between 1.0 cm2 and 25 cm2 at screening and treatment visits
Adequate circulation to the affected foot measured by TCOM, SPP, ABI, arterial Doppler ultrasound, or Toe Brachial Index within 3 months
Offloading of the ulcer for at least 14 days before treatment visit
Females of childbearing potential must use contraception and undergo pregnancy testing
Willingness and ability to participate and comply with weekly visits
Signed informed consent form before screening procedures

You will not qualify if you...

Ulcer caused by a condition other than diabetes
Ulcer suspicious for cancer or requiring biopsy
Infected ulcer
Recent or ongoing treatment with immune-suppressants, chemotherapy, or topical steroids near the ulcer
Use of investigational drugs or devices within 30 days before screening
History of radiation at the ulcer site
Ulcer treated or needing prohibited therapies
Previous diagnosis of HIV or Hepatitis C
Conditions compromising ability to complete the study or poor treatment adherence
Osteomyelitis or bone infection in the affected foot within 30 days
Pregnant or breastfeeding
Poor metabolic control with HbA1c over 12.0 within last 90 days
End stage renal disease with serum creatinine ≥3.0 mg/dL within 6 months
Acute Charcot Neuroarthropathy in the affected limb
Ulcer area reduced by 30% or more after 14 days of standard care prior to randomization

Research Team

Frank Burrows III, MBA, EMT, BCMAS, CWCA

Mora Melican, PH.D.

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Study Comparing Amniotic Membrane Allografts and Standard Care for Treating Chronic Diabetic Foot Ulcers

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria