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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00338702
Eligibility Criteria:
Inclusion Criteria:
* Patient is greater than 18 years of age
* Patient has Type I or Type II Diabetes
* Patient must be able to understand English (self or translator) and give written, informed consent
* Patient has a plantar forefoot ulcer(s) beneath metatarsal head or toe ulcer which has been present for at least 4 weeks, and has received best practice care
* Evidence of adequate arterial perfusion: Toe plethysmography reading of
* 45 mmHg or Transcutaneous oxygen measurement of ≥ 30mmHg
* Patient is appropriately offloaded (contact cast, pneumatic walking cast)
* Infection and/or osteomyelitis have been ruled out or are being treated
* Patients must have a platelet count greater than150,000/mm3
* Orthopedic assessment has been completed to rule out mechanical source of ulceration
* Patients with following skeletal deformities could be included -
1. Tendoachillis contracture - after tendoachillis contracture lengthening has been done
2. Charcot arthropathy with concurrent surgical intervention
3. Toe deformities ( hallus valgus, significant claw toe deformities) with/after surgical intervention
4. Major axial malalignment (hindfoot varus/valgas, pes planus, pes cavus) with/after surgical intervention
* Patients taking clopidogrel (Plavix) and aspirin could be included in the study. Patients taking aspirin for non medical reason will be asked to discontinue the medicine one week before the start of treatment.
Exclusion Criteria:
* TcPO2 \<30 mmHg and/or toe plethysmography readings of less then 45 mmHg
* Limb ischemia requiring re-vascularization or impending amputation
* Untreated wound infection or osteomyelitis
* Bleeding disorders, hemophilia, sickle cell disease, thrombocytopenia,and leukemia or blood dyscrasias
* Anemia with hemoglobin level less than 100 g/L will be included as exclusion criteria.
* Patient is taking immunosuppressive agents (e.g. corticosteroids, chemotherapeutic agents, transplant medications)
* Current treatment for malignancy or neoplastic disease or collagen vascular disease
* Patient has a highly communicable disease or diseases that may limit follow - up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis)
* Patients taking anticoagulants like heparin or coumadin or others which may hinder in clot (thrombin) formation
* Ulcers resulting from electrical, chemical, radiation burns
* Serum creatinine level \>110 umol/L
* HbA1c \> 9%
* Currently participating in another investigation study
* Ulcer with exposed bone or tendon
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00338702
Study Brief:
Protocol Section:
NCT00338702