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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00304733

Enrollment

Registered

2006-03-20

Start date

2001-08-31

Completion date

2005-04-30

Last updated

2006-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Foot Ulceration in Individuals With Diabetes

Keywords

neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading

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.

Interventions

DEVICEcast vs. shoe

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
wound surface area reduction	—

Secondary

Measure	Time frame
time to wound healing (days)	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026