Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

NCT01657474 | Completed

• 1 other identifier: EFDFU002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Mean time to healing

  up to 12 Week

Secondary Outcomes (2)

• Proportion of completely healed ulcers

  Week 4 and Week 12

• Percent change in wound area

  Week 4 and Week 12

Study Arms (2)

Weekly Application of EpiFix

EXPERIMENTAL

Weekly application of EpiFix plus standard of care

Other: Weekly application of EpiFix plus standard of care

Biweekly application of EpiFix

EXPERIMENTAL

Biweekly application of EpiFix plus standard of care

Other: Biweekly application of EpiFix plus standard of care

Interventions

Weekly application of EpiFix plus standard of care OTHER

Weekly Application of EpiFix

Biweekly application of EpiFix plus standard of care OTHER

Biweekly application of EpiFix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 before enrollment/randomization, with documented failure of prior treatment 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 3cm of the study wound
• Wound must be present anatomically on the plantar surface of the foot
• Patient's ulcer must exhibit no clinical signs of infection.
• 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 Creatine less then 3.0mg/dl
• HbA1c less than 12%
• 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, OR
• ABIs with results of ≥0.7 and ≤1.2, OR

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.
• 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
• Patient who are pregnant or breast feeding
• Patient who are taking medications that are considered immune system modulator which could affect graft incorporation.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (2)

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

Professional Education and Research Institute

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Charles M. Zelen, DPM

  Professional Education and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (2)