Diabetic Foot UlcerNCT01693133
Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers
A study of Diabetic Foot Ulcer, run by MiMedx Group, Inc. at 20 sites in United States.
Trial summary
The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 20 sitesUnited States
- Study dates
- Jul 2012to Jun 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
- Male or female age 18 or older.
- The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
- Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2. Debridement will be done prior to randomization, if clinically indicated.
- Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
- Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of 30 days before enrollment/randomization, with documented failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of therapy immediately prior to randomization when treated with standard protocol of care).
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- Affected leg has been offloaded (removable walker or total contact cast) for >14 consecutive days prior to randomization.
- Serum Creatinine less than 3.0mg/dl (within last 6 months).
- HbA1c less than 12% within previous 60 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 foot.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
Who cannot join
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-tobone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
- Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
- Known history of poor compliance with medical treatments.
- Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
- Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
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- Patients currently receiving radiation therapy or chemotherapy.
- Known or suspected local skin malignancy to the index diabetic ulcer.
- Patients diagnosed with autoimmune connective tissue diseases.
- Non-revascularizable surgical sites.
- Active infection at index site or currently being treated with antibiotics
- 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. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days.
- Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.
- Known allergy to Gentamicin sulfate or Streptomycin sulfate.
- Active Charcot deformity or major structural abnormalities of the foot.
- Wounds that are greater than one year in duration without intermittent closure.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Stockdale Podiatry Group
Bakersfield, California, 93309
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Center for Clinical Research Inc
Castro Valley, California, 94546
Dorn VA
Columbia, South Carolina, 29209
Center for Clinical Research, Inc.
Eugene, Oregon, 97401
MetroWest Medical Center
Framingham, Massachusetts, 01702
Valley Vascular Surgery Associates
Fresno, California, 93720
Limb Preservation Platform
Fresno, California, 93721
Novak Urgent Care and Family Practice
Indio, California, 92201
Loma Linda VA Medical Center
Loma Linda, California, 92357
Foot & Ankle Clinic
Los Angeles, California, 90057
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
IMC Wound Care
Murray, Utah, 84157
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
Center for Clinical Research, Inc.
Sacramento, California, 95628
LDS Hospital
Salt Lake City, Utah, 84143
Center for Clinical Research
San Francisco, California, 94115
Jobst Vascular Institute, Promedica Toledo Hospital
Toledo, Ohio, 43606
Coastal Podiatry, Inc.
Virginia Beach, Virginia, 23464
South Shore Hospital
Weymouth, Massachusetts, 02190
About this study
Official title: A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers
The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Standard of Care: Moist Wound Therapy and Offloading, EpiFix plus Standard of Care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care: Moist Wound Therapy and OffloadingOther
Standard of Care: Moist Wound Therapy and Offloading
EpiFix plus Standard of CareOther
Weekly application of EpiFix and Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard of Care: Moist Wound Therapy and Offloading Receives: Other: Standard of Care: Moist Wound Therapy and Offloading |
| EpiFix plus Standard of Care | Experimental | Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading) Receives: Other: EpiFix plus Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with complete closure of the study ulcer
Assessed by the Investigator, during treatment (Visits 1 - 13).
Measured: Week 12
Secondary outcomes (5)
Time to complete closure for both groups
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 Week 12
Incidence of ulcer recurrence
Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.
Measured: Up to Week 16
Quality of Life
Change in quality of life metrics as measured by SF-36 Health Survey and changes in the patient's reported pain scores as measured by the Visual Analog Scale.
Measured: Up to Week 12
Cost effectiveness of treatment
Cost effectiveness of treatment regimen.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- 132 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
- NCT01693133
- Sponsor's protocol ID
- EFDFU003
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2012
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. 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 Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01693133
- Acronym / sponsor ID
- EFDFU003
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Sep 2012 (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.
The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Standard of Care: Moist Wound Therapy and OffloadingStandard of Care: Moist Wound Therapy and Offloading |
| EpiFix plus Standard of Care | Experimental | Other: EpiFix plus Standard of CareWeekly application of EpiFix (up to 12 week) and standard of care (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 (14 listed)
- Male or female age 18 or older.
- The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
- Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2. Debridement will be done prior to randomization, if clinically indicated.
- Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
- Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
Key exclusion criteria (17 listed)
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-tobone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
- Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
- Known history of poor compliance with medical treatments.
- Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
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 |
|---|---|---|
| Standard of Care: Moist Wound Therapy and OffloadingStandard of Care: Moist Wound Therapy and Offloading | Other | Control |
| EpiFix plus Standard of CareWeekly application of EpiFix and Standard of Care | Other | EpiFix plus Standard of Care |
Primary outcome
Percentage of subjects with complete closure of the study ulcer
Time frame: Week 12
Assessed by the Investigator, during treatment (Visits 1 - 13).
5 secondary outcomes
Time to complete closure for both groups
Time frame: Up to 12 Weeks
Rate of wound closure
Time frame: Up to Week 12
Incidence of ulcer recurrence
Time frame: Up to Week 16
Quality of Life
Time frame: Up to Week 12
Cost effectiveness of treatment
Time frame: Up to Week 12
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 24 Sep 2018.
Related trials for Diabetic Foot Ulcer
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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
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetic Foot Ulcer, run by MiMedx Group, Inc. at 20 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 14 inclusion and 17 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Percentage of subjects with complete closure of the study ulcer (time frame: Week 12). 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 24 Sep 2018.