Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers

ILS Hospital, Salt Lake

Status: Completed

Conditions: Offloading; Diabetic Foot Ulcer (DFU)

Treatments: Device: Posterior slab cast; Device: Total contact cast

Study type: Interventional

Funder types: Other

Identifiers

NCT07111741

ILSS/EC/0012-DFU/2022

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People with diabetes
• a single neuropathic plantar DFU
• Ulcer belonging to Wagner grade 2 and 3

Exclusion criteria

• Persons with bilateral DFUs
• gout
• peripheral arterial disease (ABPI <0.8)
• stage 4 and 5 chronic kidney disease [estimated glomerular filtration rate (eGFR) <30 ml/min/m2]
• active Charcot arthropathy
• history of steroid intake within the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

51 patients with plantar diabetic foot ulcer

Active Comparator group

Description:

Total contact cast used for offloading the ulcer

Treatment:

Device: Total contact cast

48 patients with plantar diabetic foot ulcer

Active Comparator group

Description:

Posterior slab cast used for offloading the ulcer

Treatment:

Device: Posterior slab cast