DHACM vs Other Commercially Available Treatments

NCT01921491 | Completed

• 1 other identifier: EFDFU005
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot ulcers (DFUs).

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Proportion of ulcers achieving 100% epithelialization in the dHACM group vs other commercially available product and control.

  Visitrak Wound Measurement System

  6 weeks

Secondary Outcomes (2)

• Proportion of patients achieving 100% epithelialization in dHACM group vs other commercially available product and control.

  12 weeks

• Cost effectiveness of each treatment modality.

  12 weeks

Study Arms (3)

Standard of Care

OTHER

Surgical debridement of DFU, 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

Other Commercially Available Product

ACTIVE COMPARATOR

Application of commercially available product with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional application of commercially available product will be applied weekly at weeks 2-11.

Procedure: Dressing Application; Device: Offloading

dHACM

EXPERIMENTAL

Application of dHACM with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional piece of dHACM will be applied weekly at weeks 2-11.

Procedure: Dressing Application; Device: Offloading

Interventions

Dressing Application PROCEDURE

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

Other Commercially Available Product; dHACM

Offloading DEVICE

Provision of offloading cast walker or similar sponsor-approved device. May convert into "instant total contact cast" and/or add felt/foam to supplement offloading.

Other Commercially Available Product; Standard of Care; dHACM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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. Note: 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 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, 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 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

• MiMedx Group, Inc.: lead

Study Sites (2)

St. Johns Outpatient Wound Center

Tulsa, Oklahoma, 74135, United States

Location

Professional Education and Research Institute, Inc.

Roanoke, Virginia, 24016, United States

Location

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

• Charles Zelen, DPM

  Professional Education and Research Institute, Inc.

  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 9, 2013
• First Posted: August 13, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (2)