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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT01098357
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
* Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification).
* Chronic ulcer of at least six weeks despite appropriate wound care.
* Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
* Well controlled infection or cellulitis (systemic antibiotherapy).
* Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
* Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index \> 0.60, or ankle systolic pressure \> 70 mmHg or toe pressure \> 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
* Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing.
* Signed informed consent before any study procedure.
Exclusion Criteria:
* Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
* Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
* Active osteomyelitis affecting the area of the target ulcer.
* Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine \> 3.0 mg/dL), poor nutritional status (albumin \< 3.0 g/dL or total protein \< 6.5 g/dL).
* Known connective tissue or malignant disease.
* Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
* Use of investigational drug/device within 30 days.
* Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days.
* Vascular reconstruction within 8 weeks. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01098357
Study Brief:
Protocol Section:
NCT01098357