Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT02587104
Eligibility Criteria:
Inclusion Criteria:
1. Subject with a DFU that meets all of the following requirements:
* Wound diabetic in origin
* Located on the dorsal or plantar surface of the foot
* Size ranging from 1 to 25 cm2 (Debridement will be done prior to measurement and treatment, if clinically indicated)
* Open a minimum of 30 days prior to treatment (Day 0)
* Failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of offloading and moist wound therapy immediately prior to treatment on Day 0)
2. Affected limb must demonstrate adequate circulation, as demonstrated by one of the tests listed below (completed \<60 days prior to Day 0)
* 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
3. General Subject Characteristics:
* Age 18 or older
* Type 1 or 2 Diabetic (criteria for the diagnosis of diabetes mellitus per ADA)
* Willing and able to provide consent and participate in all procedures necessary to complete the study
* Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
Exclusion Criteria:
1. DFUs meeting any of the criteria below:
* Non-Index wounds within 2 cm of the index DFU
* Active infection at index DFU
* Index DFU greater than one year in duration without intermittent closure
* DFU is a possible non-revascularizable surgical site
* Known or suspected local skin malignancy to the index diabetic ulcer
* Index DFU treated with biomedical or topical growth factor within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®), EpiFix®, or other scaffold materials (e.g. Oasis®, MatriStem®) within the last 30 days
2. Subjects with the following lab values at Day 0:
* HbA1C ≥ 12% at any time within previous 60 days
* Serum Creatinine ≥ 3.0mg/dl within last 6 months
3. Therapy Related Exclusions:
* Subjects previously or currently enrolled in this study
* Subjects being treated with investigational drug(s) or investigational therapeutic device(s) within 30 days
* Subjects currently receiving radiation therapy or chemotherapy
* Currently being treated with antibiotics
4. Other Exclusion Criteria:
* Active Charcot deformity or major structural abnormalities of the foot
* Known allergy to Gentamicin sulfate or Streptomycin sulfate
* Subjects diagnosed with autoimmune connective tissue diseases
* Any pathology that would limit the blood supply and compromise healing
* Known history of poor compliance with medical treatments
* Subjects who are known to be pregnant, plan to become pregnant, or are breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02587104
Study Brief:
Protocol Section:
NCT02587104