- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02870816
Prospective, Comparitive, Randomized Study of Allograft Versus Skin Substitute in Non-healing Diabetic Foot Ulcers
A Prospective, Randomized, Multi-Center Comparative Study of Amniotic Membrane Wound Graft Application Versus Tissue Engineered Skin Substitute in the Management of Non Healing Diabetic Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
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Martinsville, Virginia, United States, 24112
- Martinsville Research Institute
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Roanoke, Virginia, United States, 24016
- Professional Education and Research Institute
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Roanoke, Virginia, United States, 24013
- Shenandoah Lower Extremity Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 duration, with documented failure of prior treatment to heal the wound.
- Patient's ulcer must exhibit no clinical signs of infection.
- Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle
- Additional wounds may be present but not within 3cm of the study wound
- 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 Creatinine less then 3.0mg/dl.
- HbA1c less than 12% taken prior to randomization .
Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 90 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
Exclusion Criteria:
- 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 as noted by serum blood testing within the last six months.
- Patients with a known history of poor compliance with medical treatments.
6 Patients who are presently participating in another clinical trial.
7. Patients who are currently receiving radiation therapy or chemotherapy.
8. Patients with known or suspected local skin malignancy to the index diabetic ulcer.
9. Patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
10. Patients with uncontrolled autoimmune connective tissues diseases.
11. Non-revascularizable surgical sites.
12. Active infection at site.
13. Any pathology that would limit the blood supply and compromise healing.
14. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
15. Patient who are pregnant or breast feeding .
16. Patient who are taking medications that are considered immune system modulator.
17. Patient taking a cox-2 inhibitor.
18. Patient with wounds healing greater then 20% during the screening period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Tissue engineered skin substitute
Application of tissue engineered skin substitute 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 skin substitute will be applied weekly at weeks 2-11.
|
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.
Application of skin substitute and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
|
EXPERIMENTAL: Amnionic membrane graft
Application of amnionic membrane graft 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 amnionic membrane graft will be applied weekly at weeks 2-11
|
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.
Application of amnion membrane graft and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of participants out of 60 with complete healing of their diabetic foot ulcers as measured by complete epithialization of the foot wound comparing the two active treatment groups
Time Frame: 6 weeks
|
Examine the number of patient that go onto complete healing
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of wounds healed
Time Frame: 12 weeks
|
examine the number of wounds that go on to complete healing
|
12 weeks
|
Time to healing/complete closure
Time Frame: 6 weeks
|
examine the time it take for the patient to go onto complete healing
|
6 weeks
|
Time to healing/complete closure
Time Frame: 12 weeks
|
examine the time it take for the patient to go onto complete healing
|
12 weeks
|
Cost effectiveness of each treatment modality.
Time Frame: 12 weeks
|
Examine the cost to achieve closure in the wounds
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Evangelia Chnari, PhD, Director of Research and Development; Wound Care
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTF-DFU-COMP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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