Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.

Key facts

Study ID

NCT02880592

Run by

Organogenesis

People needed

89

Starts

2016-08-01

Expected to finish

2019-04-01

Last updated by the study team

2020-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years old.
• Presence of a diabetic foot ulcer, Wagner 1 or 2 grade , extending at least through the dermis or subcutaneous tissue and may involve the tendon or muscle, on any aspect of the foot provided it is below the medial aspect of the malleolus.
• The index ulcer will be the largest ulcer if 2 or more DFUs are present with the same Wagner grade and will be the only one in the study. If other ulcerations are present on the same foot they have to be more than 2 cm apart from the index ulcer.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit and less than 1 year.
• Study ulcer is a minimum of 0.75 cm2 and a maximum of 25 cm2 at first treatment visit.
• Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an ABI between 0.7 and 1.3 within 3 months of the first Screening Visit,or TBI of > 6 within 3 months of the first Screening Visit .
• The target ulcer has been offloaded for at least 14 days prior to randomization.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.

You may not qualify if…

• Study ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10 mg daily), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
• History of radiation at the ulcer site.
• Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first Screening Visit or will need to be treated with any prohibited therapies.
• Affected extremity requiring negative pressure wound therapy or subject requiring hyperbaric oxygen during the course of the trial.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
• Osteomyelitis or bone infection of the affected foot as verified by X-ray within 30 days prior to Randomization.
• Subject is pregnant or breast feeding.
• Presence of diabetes with poor metabolic control as documented with an HgA1c > 12.0 within last 90 days.
• Patients with end stage renal disease.
• Index ulcer has reduced in area by 20% or more after 14 days of standard of care from the first screening visit (S1) to the TV1/randomization visit.

Where it is running

• Summit Health Hospital — Chambersburg, Pennsylvania, United States
• The Foot and Ankle Wellness Center — Ford City, Pennsylvania, United States
• Armstrong County Memorial Hospital — Kittanning, Pennsylvania, United States
• SerenaGroup Research Institute — Pittsburgh, Pennsylvania, United States
• Martin Foot and Ankle — York, Pennsylvania, United States
• GF Professional Research — Miami Lakes, Florida, United States
• Barry University Clinical Research — North Miami Beach, Florida, United States
• Henry Ford Macomb Hospital — Clinton Township, Michigan, United States

Full record on ClinicalTrials.gov

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