- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331147
Allogenic Dermis Versus Standard Care in the Management of Diabetic Foot Ulcers
A Prospective, Randomized, Comparative Parallel Study of Allogenic Dermis Graft in the Management of Diabetic Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Professional Education and Research Institute
-
Roanoke, Virginia, United States, 24013
- Shenandoah Lower Extremity Research
-
Salem, Virginia, United States, 24153
- Foot and Ankle Associates of Southwest VA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients age 18 or older.
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- Patient's ulcer must be diabetic in origin and larger than 1 cm2.
- 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 conventional ulcer therapy 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 3 cm of the study wound.
- Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
- Patient's ulcer must exhibit no clinical signs of infection.
- Serum Creatinine less than 3.0mg/dl within last six months.
- HbA1c less than or equal to 12% within last 90 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,
- 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 tendon, muscle, capsule or 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 25 cm2.
- 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 within the last six months.
- 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.
- 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.
- Patients who are pregnant or breast feeding.
- Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
- Patients with known hypersensitivity to components of any treatment used in the trial.
- Wounds greater than one year in duration without intermittent healing.
- Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
- Patients taking Cox-2 inhibitors.
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 |
---|---|
SHAM_COMPARATOR: Standard of Care
Surgical debridement of DFU, The wound will be debrided and cleaned.
Patient ulcers will be assessed and measured weekly in cm length by width.
Application of collagen alginate and gauze dressing application to be changed daily by patient.
Patient will practice off loading
|
Patient will be offloaded in a diabetic camboot after treatment
|
ACTIVE_COMPARATOR: Human Dermis
Application of Human Allogenic Dermis with Dressing Application, to be changed weekly. Patient would will be measured in cm length by width weekly Patient will practice Offloading. If the ulcer has not closed completely, an additional piece of Human Dermis will be applied weekly at weeks 2-11 in a similar fashion |
Patient will be offloaded in a diabetic camboot after treatment
Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
proportion of ulcers completely healed by the allogenic dermal graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the proportion of ulcers completely healed at 4 weeks
Time Frame: 4 weeks
|
4 weeks
|
Compare the proportion of ulcers completely healed at 12 weeks
Time Frame: 12 weeks
|
12 weeks
|
Mean time to healing
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charles M Zelen, DPM, CEO; Professional Education and Research Institute
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
- 20142081
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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