Prospective, Comparitive, Randomized Study of Allograft Versus Skin Substitute in Non-healing Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs).

Key facts

Study ID

NCT02870816

Run by

Professional Education and Research Institute

People needed

60

Starts

2016-08-31

Expected to finish

2018-06-14

Last updated by the study team

2021-12-08

Who can join

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

You may qualify if…

• Male or female age 18 or older
• Informed consent must be obtained
• Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
• Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
• Ulcer must be present for a minimum of four weeks duration, with documented failure of prior treatment to heal the wound.
• Patient's ulcer must exhibit no clinical signs of infection.
• Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle
• Additional wounds may be present but not within 3cm of the study wound
• Patient is of legal consenting age.
• Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
• Serum Creatinine less then 3.0mg/dl.
• HbA1c less than 12% taken prior to randomization .
• Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 90 days:
• Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
• ABIs with results of ≥0.7 and ≤1.2, OR
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg

You may not qualify if…

• Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
• Patients whose index diabetic foot ulcers are greater than 25cm2.
• Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days.
• Patients whose serum creatinine levels are 3.0mg/dl or greater as noted by serum blood testing within the last six months.
• Patients with a known history of poor compliance with medical treatments.
• 6 Patients who are presently participating in another clinical trial.
• Patients who are currently receiving radiation therapy or chemotherapy.
• Patients with known or suspected local skin malignancy to the index diabetic ulcer.
• Patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
• Patients with uncontrolled autoimmune connective tissues diseases.
• Non-revascularizable surgical sites.
• Active infection at site.
• Any pathology that would limit the blood supply and compromise healing.
• Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
• Patient who are pregnant or breast feeding .
• Patient who are taking medications that are considered immune system modulator.
• Patient taking a cox-2 inhibitor.
• Patient with wounds healing greater then 20% during the screening period.

Where it is running

• Martinsville Research Institute — Martinsville, Virginia, United States
• Shenandoah Lower Extremity Research Institute — Roanoke, Virginia, United States
• Professional Education and Research Institute — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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