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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT01013792
Eligibility Criteria:
Inclusion Criteria:
1. Is the subject 18 years of age or older?
2. Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks?
3. Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
4. Does the subject show evidence of neuropathy?
5. Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis?
6. Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?
7. Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?
8. Is the subject willing to have photos taken of their wound and permit use of the photos in publications?
9. Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information?
10. Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 - 1.2; or if the ABI is greater than 1.2, does the subject show toe pressures \>40 mmHg, or transcutaneous oximetry (TcPO2) \> 40 mm Hg, or does the subject show adequate circulation on an arterial Doppler study? (ABI or Doppler results must be \< 45 days old.)
11. Is the subject able to comply with the protocol requirements?
12. If the subject is a woman of child bearing potential is she practicing an acceptable form of birth control as determined by the Investigator, and is she willing to have a pregnancy test?
Exclusion Criteria:
1. Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
2. Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
3. Does the subject have an infection requiring systemic antibiotic treatment?
4. Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
5. Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.)
6. Does the subject have Lupus or Crohn's disease?
7. Does the subject have an oxygen dependency?
8. Has the subject received hyperbaric oxygen therapy within the previous 90 days?
9. Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit?
10. Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?
11. Has the subject received Dermagraft®, Apligraf, or any other biologically active wound care product, or used Regranex Gel®, KGF, TGFβ or another topical growth factor to the study ulcer within the 30 days prior to the Screening visit?
12. Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents?
13. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
14. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
15. Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01013792
Study Brief:
Protocol Section:
NCT01013792