Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers
NCT07111741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2025-08-08
Summary
The goal of this clinical trial is to compare wound healing and foot related outcomes in people with plantar diabetic foot ulcer using Total contact cast (TCC) or Posterior slab cast (PSC). Ninety-nine people with neuropathic DFUs were randomized to use TCC (n=51) or PSC (n=48) together with standard of care for up to 6 months.
Researchers will compare rate of healing of ulcer at the end of 6 months, percentage reduction in the surface area, time taken to heal and patient satisfaction.
Participants will:
* Use TCC or PSC as off-loading till the ulcer heals for upto 6 months
* Visit the clinic once every 2 weeks for follow ups when inspection of the wound will be done for wound dressing, wound debridement and infection control when necessary
Conditions
- Diabetic Foot Ulcer (DFU)
- Offloading
Interventions
- DEVICE
-
Total contact cast
Arm with 51 patients was given total contact cast for offloading DFU
- DEVICE
-
Posterior slab cast
Arm with 48 patients were given posterior slab cast for offloading DFU
Sponsors & Collaborators
-
ILS Hospital, Salt Lake
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-04
- Primary Completion
- 2023-06-29
- Completion
- 2024-04-10
Countries
- India
Study Locations
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