This trial is active, not recruiting.

Condition neuropathic foot ulceration in individuals with diabetes
Treatment cast vs. shoe
Sponsor Rehabilitation Centre Amsterdam
Collaborator ConvaTec Inc.
Start date August 2001
End date April 2005
Trial size 43 participants
Trial identifier NCT00304733, 2024


Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

wound surface area reduction
time frame:

Secondary Outcomes

time to wound healing (days)
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - confirmed diabetes - neuropathic ulcer grade 1/2 (wagner scale) - confirmed sensory neuropathy Exclusion Criteria: - osteomyelitis patients unable to walk - life threatening co-morbidity ankle/brachial index , 0.4

Additional Information

Official title Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Description In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.
Trial information was received from ClinicalTrials.gov and was last updated in March 2006.
Information provided to ClinicalTrials.gov by Rehabilitation Centre Amsterdam.