Diabetic Foot UlcerNCT01657474
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
A study of Diabetic Foot Ulcer, run by MiMedx Group, Inc. at 2 sites in United States.
Trial 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. 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
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Nov 2013
- 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
- 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
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- 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
- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
Who cannot join
- 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
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- 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.
- Allergy to Gentamycin or Streptomycin
- Wounds greater than one year in duration without intermittent healing
- Wound improving greater than 20% over the first two weeks of the trial using standard of care dressing and Cam Boot
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Professional Education and Research Institute
Roanoke, Virginia, 24016
Professional Education and Research Institute
Salem, Virginia, 24153
About this study
Official title: A Prospective, Randomized, Comparative Study of Amniotic Membrane Wound Graft With Weekly Versus BiWeekly Application In the Management of Diabetic Foot Ulcers
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
- Being tested
- Weekly application of EpiFix plus standard of care, Biweekly application of 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.
Weekly application of EpiFix plus standard of careOther
Biweekly application of EpiFix plus standard of careOther
| Study group | Role | What they receive |
|---|---|---|
| Weekly Application of EpiFix | Experimental | Weekly application of EpiFix plus standard of care Receives: Other: Weekly application of EpiFix plus standard of care |
| Biweekly application of EpiFix | Experimental | Biweekly application of EpiFix plus standard of care Receives: Other: Biweekly application of EpiFix plus standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to healing
Measured: up to 12 Week
Secondary outcomes (2)
Proportion of completely healed ulcers
Measured: Week 4 and Week 12
Percent change in wound area
Measured: Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionNov 2013
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles M. Zelen, DPM, Principal investigator, Professional Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657474
- Sponsor's protocol ID
- EFDFU002
- Status last verified
- Dec 2013
- First submitted
- 2 Aug 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative Study of Amniotic Membrane Wound Graft With Weekly Versus BiWeekly Application In the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01657474
- Acronym / sponsor ID
- EFDFU002
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Aug 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Application of EpiFix | Experimental | Other: Weekly application of EpiFix plus standard of careWeekly application of EpiFix plus standard of care |
| Biweekly application of EpiFix | Experimental | Other: Biweekly application of EpiFix plus standard of careBiweekly application of EpiFix plus standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| 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 |
Primary outcome
Mean time to healing
Time frame: up to 12 Week
2 secondary outcomes
Proportion of completely healed ulcers
Time frame: Week 4 and Week 12
Percent change in wound area
Time frame: Week 4 and 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 11 Dec 2013.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
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.
Charles M. Zelen, DPM principal investigator
Professional Education and Research Institute
2 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 2 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 16 inclusion and 18 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Mean time to healing (time frame: up to 12 Week). 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 11 Dec 2013.