A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers

This study has been withdrawn prior to enrollment.
(Industry support and funding not forthcoming)
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00338702
First received: June 16, 2006
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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.

Condition Intervention Phase
Diabetic Foot Ulcer
Procedure: Autologous Platelet Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Time to 25% percent closure at 6 weeks
  • Time to 50% closure at 12 weeks
  • Time to definitive closure

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: October 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338702

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: James L Mahoney, MD, FRCSC St. Michael's Hospital, Toronto
Principal Investigator: Timothy R Daniels, MD, FRCSC St. Michael Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00338702     History of Changes
Other Study ID Numbers: 1_James L Mahoney
Study First Received: June 16, 2006
Last Updated: February 4, 2009
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Diabetic
Foot
Ulcer
Autologous
Platelet
Gel

Additional relevant MeSH terms:
Diabetic Angiopathies
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 29, 2014