Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Not Applicable

• Conditions: Neuropathic Foot Ulceration in Individuals With Diabetes

• Registration Number: NCT00304733
• Lead Sponsor: Rehabilitation Centre Amsterdam

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2001-08
• Study Start: 2001-08
• Study Completion: 2005-04
• Study First Submitted: 2006-03-16
• Study First Submitted QC: 2006-03-16
• Last Update Submitted: 2006-03-16
• Study First Posted: 2006-03-20
• Last Update Posted: 2006-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
wound surface area reduction

Secondary Outcome Measures

Name	Time	Method
time to wound healing (days)

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Noord Holland, Netherlands