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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2024-04-10

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetic Foot Ulcer (DFU) Offloading

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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51 patients with plantar diabetic foot ulcer

Total contact cast used for offloading the ulcer

Group Type ACTIVE_COMPARATOR

Total contact cast

Intervention Type DEVICE

Arm with 51 patients was given total contact cast for offloading DFU

48 patients with plantar diabetic foot ulcer

Posterior slab cast used for offloading the ulcer

Group Type ACTIVE_COMPARATOR

Posterior slab cast

Intervention Type DEVICE

Arm with 48 patients were given posterior slab cast for offloading DFU

Interventions

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Total contact cast

Arm with 51 patients was given total contact cast for offloading DFU

Intervention Type DEVICE

Posterior slab cast

Arm with 48 patients were given posterior slab cast for offloading DFU

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No