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Completed

NCT Number: NCT07111741

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

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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Key information

Conditions

Diabetic Foot Ulcer (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Offloading Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ILS Hoapital, Saltlake, Kolkata

Kolkata, West Bengal, 700064, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total contact cast

Device

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

Posterior slab cast

Device

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

Primary outcomes

  1. The primary outcome measure in this study was healing of the ulcer at 6 months.

    Time frame: 6 months

    We compared the rate of healing of ulcers and time taken to heal.

Secondary outcomes

  1. The secondary outcome measure was the rate of wound size reduction at 4 weeks and patient satisfaction.

    Time frame: 6 Months

    Healing rates will be measured by the percentage of ulcers healed or wound closure, based on clinical assessment and standardized wound measurement techniques (i.e., wound area reduction). Patient satisfaction was measured using the Likert scale 1-5 (1= very dissatisfied, 5=very satisfied).

Sponsors and collaborators

Lead sponsor

ILS Hospital, Salt Lake

Other

Registry information

Official study title

Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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