Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

NCT02844660 | Completed

• 1 other identifier: ECDFU001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 13

Brief Summary

A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)

Conditions

Diabetic Foot Ulcers

Keywords

Diabetes Mellitus; Foot Diseases; Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• Complete Ulcer Closure

  The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation

  12 weeks

• Study Safety Measurement

  The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.

  12 weeks

Secondary Outcomes (6)

• Time to complete closure

  up to 12 weeks

• Rate of wound closure

  up to 12 weeks

• Incidence of ulcer recurrence

  up to 12 weeks

• Quality of Life Health Survey

  up to 12 weeks

• Quality of Life-Pain

  up to 12 weeks

Study Arms (2)

EpiCord

EXPERIMENTAL

Weekly application of EpiCord and standard of care (moist wound therapy and offloading)

Biological: EpiCord

Standard of Care

ACTIVE COMPARATOR

Weekly application of moist wound therapy and offloading

Other: Standard of Care

Interventions

EpiCord BIOLOGICAL

Weekly application of EpiCord and standard of care (moist wound therapy and offloading)

EpiCord

Standard of Care OTHER

moist wound therapy and offloading

Standard of Care

Eligibility Criteria

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

You may qualify if:

• \. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
• \. Index ulcer characteristics:
• a. Ulcer present for ≥ 30 days prior to randomization (Day 0) b. Index ulcer is located below the ankle c. Index ulcer area after debridement is ≥ 1 cm² and ≤ 15 cm² at the randomization visit 3. Subject has completed 14-day run-in period with ≤ 30% wound area reduction post-debridement.
• \. Subject 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 ≥ 30 mmHg, OR
• ABIs with results of ≥ 0.7 and ≤ 1.2, OR
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot 5. Age ≥ 18 6. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
• Index Ulcer Assessment:
• Penetrates down totendon, or bone
• Presence of another diabetic foot ulcer within 3 cm of the index ulcer
• Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot
• Exhibits clinical signs and symptoms of infection
• Known or suspected local skin malignancy to the index diabetic ulcer
• Wound duration \> one year without intermittent closure
• Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (13)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Arizona Regional Medical Research (ARMR)

Tucson, Arizona, 85710, United States

Location

ILD Research

Carlsbad, California, 92009, United States

Location

Limb Preservation Platform, Inc

Fresno, California, 93710, United States

Location

Foot and ankle clinic

Los Angeles, California, 90057, United States

Location

Doctors Research Network

Miami, Florida, 33143, United States

Location

Joseph M. Still Burn Center at Doctors Hospital

Augusta, Georgia, 30909, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Advanced Foot & Ankle Center

Las Vegas, Nevada, 89119, United States

Location

Foot and Ankle Center

Haverford, Pennsylvania, 19041, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

Ambulatory Foot & Ankle Center, PC

Hampton, Virginia, 23666, United States

Location

Costal Podiatry

Virginia Beach, Virginia, 23464, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Diseases; Foot Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• William Tettelbach, MD

  Intermountain Medical Center

  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: July 8, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 13, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)