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:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02166294
Eligibility Criteria:
Inclusion Criteria:
1. Between 18 years and 80 years of age inclusive
2. Confirmed diagnosis of Type I or Type II Diabetes
3. Males and Females diagnosed with a diabetic foot ulcer that is 1-25cm²
4. At least one foot ulcer that is UT Grade IA
5. Evidence of proper circulation which includes: An Index Ulcer defined as chronic (presence of wound for \> 4 weeks) but not present for more than 52 weeks at the Screening Visit
6. The Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
7. The Index Ulcer extends into the dermis or subcutaneous tissue with no evidence of exposed muscle, tendon, bone, or joint capsule
8. Wound is free of necrotic debris and clinical signs of infection
9. Patient has adequate circulation to the foot
10. In patients with non-compressible ankle vessels there is adequate flow to the foot.
Exclusion Criteria:
1. The Index Ulcer is of non-diabetic pathophysiology and/or over an active Charcot deformity
2. The Index Ulcer is UT Grade IB or higher (worsening)
3. Gangrene is present on any part of the affected foot
4. The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
5. Patient is currently receiving renal dialysis
6. Patient has a glycated hemoglobin A1c (HbA1c) level of \> 12%
7. Patient has significant renal impairment
8. Chronic oral steroid use \> 7.5 mg daily
9. Requiring intravenous (IV) antibiotics to treat the index wound infection
10. Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
11. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
12. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
13. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or purulent drainage from the wound site
14. Patient has active malignancy other than non-melanoma skin cancer
15. Patient's Index Ulcer has decreased by ≥ 30% during 2-week screening period
16. Patient has untreated alcohol or substance abuse at the time of screening
17. Pregnant women
18. Patient is currently enrolled or participated in another investigational device, drug, or biologic trial within 60 days of screening
19. Patient has allergy to primary or secondary dressing materials used in this trial
20. Patient has an allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM)
21. Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02166294
Study Brief:
Protocol Section:
NCT02166294