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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT00820703
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 18 and older
2. Female subjects must be a) post-menopausal, b) surgically sterilized, c) practicing abstinence, or d) using hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study
3. Diabetes mellitus (type I or II) with an HbA1c \< 10.0%
4. Diagnosis of neuropathic foot ulcer
5. Cutaneous, full thickness (University of Texas grade A1), below ankle surface ulcer between 0.5 and 5.0 cm2 post-debridement
6. A viable, granulating wound
7. Ulcer present for \> 4 weeks prior to study entry
8. An ankle brachial index between 0.70 and 1.3 measured during screening or within three months prior to the Day -14 visit
9. Signed informed consent form
Exclusion Criteria:
1. Decrease or increase in the ulcer size by 30% or more during a14 day "run-in" period
2. Cannot tolerate the off-loading method or comply with standard-of-care
3. An ulcer which shows signs of clinical infection
4. The ulcer to be treated requires operative debridement.
5. An ulcer positive for β-hemolytic streptococcus upon culture.
6. Requirement for total contact casts
7. The ulcer has more than 50% slough, significant necrotic tissue, osteomyelitis, bone, tendon, or capsule exposure
8. Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer)
9. Congestive heart failure NYHA class II - IV
10. Coronary heart disease with STEMI, CABG, or PTCA within the last 6 months
11. Active osteomyelitis of the study foot
12. Active connective tissue disease
13. Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination
14. Treatment with systemic corticosteroids (
15. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
16. Pregnancy or lactation
17. eGFR \< 25 mL/min
18. Poor nutritional status defined as an albumin \< 25 g/L
19. Significant peripheral edema
20. Known prior inability to complete required study visits during study participation
21. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
22. Use of a platelet-derived growth factor within the 28 days prior to screening
23. Use of any investigational drug or therapy within the 28 days prior to screening
24. Any other factor which may, in the opinion of the Investigator, compromise participation and follow-up in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00820703
Study Brief:
Protocol Section:
NCT00820703