A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Unity Health Toronto
- Locations
- 2
- Primary Endpoint
- Time to 50% closure at 12 weeks
Study Overview
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 been directed at therapies to improve the rate of healing.
There are a variety of growth factors which have been used to stimulate wound healing. Human platelets are an autologous source of growth factors which probably can stimulate healing. Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood. APG is rich in platelet growth factors. This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers.
This study will compare the use of autologous platelet gel ( study group) and standard care ( control group) in the treatment of diabetic plantar forefoot ulcers. This study will also compare the cost and quality of life in the two groups.
Objectives of the study:
- To determine if topical APG (autologous platelet gel) is beneficial in the treatment of diabetic foot ulcers.
- To determine if it will result in a faster rate of wound healing.
- To determine if it will improve the quality of life in patients with diabetic foot ulcers.
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 treatment of plantar forefoot ulcers.
Specific Aims Primary - Facilitation of healing of diabetic foot ulcers Secondary - Reduction in amputations and average total cost of care. Determine the impact of diabetic ulcers on patients' quality of life Research Background Foot ulcers represent a significant common complication in patients with diabetes. It is estimated that twenty percent of all patients with diabetes develop a foot ulcer which may subsequently lead to below knee amputation. 85 % of them preceded by non-healing foot ulcers.
Health care costs associated with diabetic foot wound management are staggering. Armstrong et al (1998) reported that wound care for foot ulcer patients over a two year period had mean cost of $27,000.00 U.S. In Toronto, the average cost of below knee amputations, including hospitalization and rehabilitation, is $40,000.00.
Wound healing in the context of diabetes is a challenge for both the health care provider and the patient. In a systematic review conducted by Margolis et al (1999), wound healing outcomes using best practices have yielded only 24% at 12 weeks, 31% in 20 weeks.
Falanga & Sabolinski (2001) identified that initial wound size reduction of 0.1 cm/week is highly predictive of wound closure whereas initial healing rates 0.06 cm or less predict non-healing. Similarly, 51% percent reduction in 4 weeks was found to be a good predictor of achieving wound closure (Margolis et al, 1999). Some wounds do not respond and considerable effort has been directed at therapies to improve the rate of healing in this situation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 -
- •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 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
Outcomes
Primary Outcomes
Time to 50% closure at 12 weeks
Time to 25% percent closure at 6 weeks
Time to definitive closure
Secondary Outcomes
No secondary outcomes reported