Status:
WITHDRAWN
A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers
Lead Sponsor:
Unity Health Toronto
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Foot ulcers represent a significant common complication in patients with diabetes. Wound healing is a challenge. Some wounds do not respond to the best practices in wound care. Considerable effort has...
Detailed Description
Study Design This will be a single center, randomized, controlled, prospective study comparing the use of autologous platelet gel (study group) and traditional moist dressing (control group) in the tr...
Eligibility Criteria
Inclusion
- 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 -
- Tendoachillis contracture - after tendoachillis contracture lengthening has been done
- Charcot arthropathy with concurrent surgical intervention
- Toe deformities ( hallus valgus, significant claw toe deformities) with/after surgical intervention
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00338702
Start Date
March 1 2008
End Date
October 1 2009
Last Update
August 28 2023
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8