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

Rehabilitation Centre Amsterdam43 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neuropathic Foot Ulceration in Individuals With Diabetes

Interventions

cast vs. shoeDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

wound surface area reduction

Secondary Outcomes

time to wound healing (days)

Data from ClinicalTrials.gov

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