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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT01472432
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* Oral hypoglycemic agents treatment
* Chronic foot ulcers
* Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen test \>30 -mmHg, anklebrachial index values \> 0.7 and \< 1.2 with toe pressure \> 30 mmHg, or Doppler arterial aveforms that were triphasic or biphasic at the ankle of the affected leg
* Written consensus
Exclusion Criteria:
* Active Charcot disease
* Ulcers resulting from electrical, chemical, or radiation burns
* Collagen vascular disease
* Ulcer malignancy
* Untreated osteomyelitis, or cellulitis
* Ulcer treatment with normothermic or hyperbaric oxygen therapy
* Concomitant medications such as corticosteroids, immunosuppressive medications, or -chemotherapy
* Recombinant or autologous growth factor products
* Skin and dermal substitutes within 30 days of study start
* Use of any enzymatic debridement treatments
* Pregnant or nursing mothers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01472432
Study Brief:
Protocol Section:
NCT01472432