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

Rehabilitation Centre Amsterdam

Status: Unknown

Conditions: Neuropathic Foot Ulceration in Individuals With Diabetes

Treatments: Device: cast vs. shoe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00304733

2024

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind