Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

Status unconfirmed · Not applicable

Conditions studied: Diabetic Foot, Foot Ulcer; Diabetic

In brief

This is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period

Key facts

Study ID

NCT02399826

Run by

Lower Extremity Institute for Research and Therapy

People needed

40

Starts

2015-03-01

Last updated by the study team

2016-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients age 18 or older.
• Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
• Patient's ulcer must be diabetic in origin and larger than 1 cm2.
• 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 before enrollment randomization, with documented failure of conventional ulcer therapy to heal the wound.
• A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
• Additional wounds may be present but not within 3 cm of the study wound.
• Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
• Patient's ulcer must exhibit no clinical signs of infection.
• Serum Creatinine less than 3.0mg/dl within last six months.
• HbA1c less than or equal to 12% within last 90 days.
• Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
• Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg,
• 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 tendon, muscle, capsule or 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 25 cm2.
• 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 within the last six months.
• Patients with a known history of poor compliance with medical treatments.
• Patients who have been previously randomized into this study, or 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 diagnosed with 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.
• Patients who are pregnant or breast feeding.
• Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
• Patients with known hypersensitivity to components of any treatment used in the trial.
• Wounds greater than one year in duration without intermittent healing.
• Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
• Patients taking Cox-2 inhibitors.

Where it is running

• Lower Extremity Institute of Research and Therapy — Canfield, Ohio, United States (enrolling)
• Martinsville Research Institute — Danville, Virginia, United States (enrolling)
• Shenandoah Lower Extremity Research Institute — Troutville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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