Diabetic Foot UlcersNCT02844660
Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
A study testing EpiCord in people with Diabetic Foot Ulcers, run by MiMedx Group, Inc. at 13 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- EpiCord
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- 2. Index ulcer characteristics:
- 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.
- 4. 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
Show all 33Show fewer
- 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:
- In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
- In the last 7 days - Hyperbaric oxygen (HBO) therapy
- In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy
- In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study
- In the last 30 days - study ulcer treatment with any biological skin substitutes, including EpiCord, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix, Grafix, etc.)
- In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
- In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot
- Subject criteria that will make subject ineligible for enrollment:
- Known osteomyelitis or active cellulitis at wound site
- Hemoglobin A1C >12 in the last 60 days prior to randomization
- History of Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Known history of poor compliance with medical treatments
- Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited
- Subjects currently receiving radiation therapy or chemotherapy
- Patients currently on dialysis or planning to start dialysis
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Joseph M. Still Burn Center at Doctors Hospital
Augusta, Georgia, 30909
Central Research Associates
Birmingham, Alabama, 35205
ILD Research
Carlsbad, California, 92009
Limb Preservation Platform, Inc
Fresno, California, 93710
Ambulatory Foot & Ankle Center, PC
Hampton, Virginia, 23666
Foot and Ankle Center
Haverford, Pennsylvania, 19041
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119
Foot and ankle clinic
Los Angeles, California, 90057
Futuro Clinical Trials
McAllen, Texas, 78501
Doctors Research Network
Miami, Florida, 33143
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Arizona Regional Medical Research (ARMR)
Tucson, Arizona, 85710
Costal Podiatry
Virginia Beach, Virginia, 23464
About this study
Official title: A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
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)
Read the detailed description
This is a prospective, multicenter, randomized controlled trial. The trial will include approximately 66 subjects in up to 10 experienced clinical centers in the United States. The estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After completing a 2-week screening period, the subjects will be followed for at least 16 weeks post-randomization.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- EpiCord, Standard of Care
- Keywords
- Diabetes Mellitus, Foot Diseases, Foot Ulcer
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Diseases, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiCordBiological
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
Standard of CareOther
moist wound therapy and offloading
| Study group | Role | What they receive |
|---|---|---|
| EpiCord | Experimental | Weekly application of EpiCord and standard of care (moist wound therapy and offloading) Receives: Biological: EpiCord |
| Standard of Care | Active comparator | Weekly application of moist wound therapy and offloading Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Ulcer Closure
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
Measured: 12 weeks
Study Safety Measurement
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
Measured: 12 weeks
Secondary outcomes (6)
Time to complete closure
As assessed by photographic evaluation and the Investigator
Measured: up to 12 weeks
Rate of wound closure
As assessed by photographic evaluation and the Investigator
Measured: up to 12 weeks
Incidence of ulcer recurrence
Incidence of ulcer recurrence at the site of the study ulcer
Measured: up to 12 weeks
Quality of Life Health Survey
Change in quality of life metrics as measured by SF-36 Health Survey
Measured: up to 12 weeks
Quality of Life-Pain
Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale
Measured: up to 12 weeks
Cost effectiveness of treatment
Cost effectiveness of treatment regime. looking at the number of grafts used on each study subject throughout the study.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Tettelbach, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844660
- Sponsor's protocol ID
- ECDFU001
- Status last verified
- Nov 2020
- First submitted
- 8 Jul 2016
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02844660
- Acronym / sponsor ID
- ECDFU001
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetes Mellitus, Foot Diseases, Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This is a prospective, multicenter, randomized controlled trial. The trial will include approximately 66 subjects in up to 10 experienced clinical centers in the United States. The estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After completing a 2-week screening period, the subjects will be followed for at least 16 weeks post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EpiCord | Experimental | Biological: EpiCordWeekly application of EpiCord and standard of care (moist wound therapy and offloading) |
| Standard of Care | Active comparator | Other: Standard of CareWeekly application of moist wound therapy and offloading |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 1. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- 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.
- 4. 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiCordWeekly application of EpiCord and standard of care (moist wound therapy and offloading) | Biological | EpiCord |
| Standard of Caremoist wound therapy and offloading | Other | Standard of Care |
Primary outcome
Complete Ulcer Closure
Time frame: 12 weeks
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
Study Safety Measurement
Time frame: 12 weeks
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
6 secondary outcomes
Time to complete closure
Time frame: up to 12 weeks
Rate of wound closure
Time frame: up to 12 weeks
Incidence of ulcer recurrence
Time frame: up to 12 weeks
Quality of Life Health Survey
Time frame: up to 12 weeks
Quality of Life-Pain
Time frame: up to 12 weeks
Cost effectiveness of treatment
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcers
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Tettelbach, MD principal investigator
Intermountain Health Care, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiCord in people with Diabetic Foot Ulcers, run by MiMedx Group, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Ulcer Closure (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.