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

NCT02399826 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Diabetic Foot; Foot Ulcer; Diabetic

Outcome Measures

Primary Outcomes (1)

• Proportion of ulcers completely healed by amniotic memrane versus standard care

  The primary objective of this study is to compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks

  6 weeks

Secondary Outcomes (1)

• Proportion of ulcers healed by amniotic membrane versus standard care

  12 weeks

Study Arms (2)

Standard of Care

OTHER

Surgical debridement of diabetic foot ulcer, followed by collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice offloading, reassessment weekly at office visit

Device: Offloading

Amniotic Membrane / Amnioband

EXPERIMENTAL

Application of Amnioband with dressing application, to be changed weekly following surgical debridement. Patient will practice offloading. If the ulcer is not closed completely Amnioband will be applied weekly at weeks 2-11

Device: Offloading; Procedure: Dressing Application

Interventions

Offloading DEVICE

Provision of an offloading cam walker or cast boot, may also convert to "total contact cast" and add felt or foam to supplement

Amniotic Membrane / Amnioband; Standard of Care

Dressing Application PROCEDURE

Application of a non adherent dressing, and a multi-layer compression dressing

Amniotic Membrane / Amnioband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Lower Extremity Institute for Research and Therapy: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (3)

Lower Extremity Institute of Research and Therapy

Canfield, Ohio, 44406, United States

RECRUITING

Martinsville Research Institute

Danville, Virginia, 24112, United States

RECRUITING

Shenandoah Lower Extremity Research Institute

Troutville, Virginia, 24019, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Lawrence Didomenico, DPM

  medical director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence Didomenico, DPM

CONTACT

3307274148

Maura Maloney, JD

CONTACT

3307160203

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

US (3)