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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT02356835
Eligibility Criteria:
Inclusion Criteria:
* 19 to 80 years of age
* Type 1 or 2 diabetes with hemoglobin A1c less than 12%
* ABI ≥ 0.7, palpable pulses and/or biphasic waveform study with Doppler
* Wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)
Exclusion Criteria:
* Have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound
* Have a severe infection in the ulcer including the presence of an abscess, cellulitis extending \> 2 cm beyond the ulcer margin, or osteomyelitis
* Have involvement of deeper tissues including bone or tendon
* Be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound
* Have received topical or systemic antimicrobial therapy within 48 hours of screening
* Have a malignancy other than skin cancer currently being treated
* Have substance abuse issues within the 6 months prior to screening
* Is a woman who is pregnant or breast feeding
* Has been treated with another investigational product within 30 days of screening
* Has been treated with tissue engineered skin or a biological therapy within 30 days of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT02356835
Study Brief:
Protocol Section:
NCT02356835