NL-OMON52242RecruitingNot Applicable
Measuring plantar pressure during total contact softcast offloading versus conventional total contact cast offloading: a pilot study - MOVE pilot study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1) Age 18 years or older
- •2) Diagnosed with diabetes mellitus
- •3) A plantar diabetic foot ulcer on the forefoot or midfoot for which
- •offloading by total contact softcast or total contact cast is indicated
Exclusion Criteria
- •1) Inability or unwillingness to provide a written declaration of informed
- •2) Unable to mobilize weight-bearing
- •3) moderate or severe diabetic foot infection, as defined by the international
- •working group on the diabetic foot / infectous diseases society of America
- •(IWGDF / IDSA).
- •4) Moderate or severe limb ischemia, as defined in the Wound, Ischemia, foot
- •Infection (WIfI) classification.
- •5) The combination of mild limb ischemia and mild infection, defined in
- •accordance with the WIfI classification and IWGDF / IDSA definitions,
- •respectively.
- •6) Severe foot deformities (e.g. Charcot neuroarthropathy-related deformity,
- •ankle arthrodesis, partial calcanectomy) which lead to increased pressure and
- •friction on the site of the DFU and thereby make adequate TCSO or TCCO
- •impossible, as judged clinically by the treating physician
Investigators
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