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

Neuropathic Foot Ulceration in Individuals With Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00304733
• Other study ID #: 2024
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2006
• Last updated: March 16, 2006
• Start date: August 2001
• Est. completion date: April 2005

Study information

• Verified date: August 2001
• Source: Rehabilitation Centre Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics CommitteeNetherlands: Onze Lieve Vrouwe Gasthuis
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Neuropathic Foot Ulceration in Individuals With Diabetes
• Ulcer

Intervention

Device:
• cast vs. shoe

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord Holland

Sponsors (3)

Lead Sponsor	Collaborator
Rehabilitation Centre Amsterdam	ConvaTec Inc., Ontwikkelingsfonds Orthopedisch maatschoeisel

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound surface area reduction
Secondary	time to wound healing (days)