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

NCT07111741 | Completed

• 1 other identifier: ILSS/EC/0012-DFU/2022
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (1)

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

  6 Months

Study Arms (2)

51 patients with plantar diabetic foot ulcer

ACTIVE COMPARATOR

Total contact cast used for offloading the ulcer

Device: Total contact cast

48 patients with plantar diabetic foot ulcer

ACTIVE COMPARATOR

Posterior slab cast used for offloading the ulcer

Device: Posterior slab cast

Interventions

Total contact cast DEVICE

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

51 patients with plantar diabetic foot ulcer

Posterior slab cast DEVICE

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

48 patients with plantar diabetic foot ulcer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ILS Hospital, Salt Lake: lead

Study Sites (1)

ILS Hoapital, Saltlake, Kolkata

Kolkata, West Bengal, 700064, India

Location

Related Links

• A mouldable fibreglass backslab device as a novel approach to offload chronic plantar foot ulcers: A retrospective observational audit; First published: 21 August, 2024,https://doi.org/10.1002/jfa2.70001
• Li B, Lin A, Huang J, Xie J, Liu Q, Yang C, Zhang Z. Total contact casts versus removable offloading interventions for the treatment of diabetic foot ulcers: a systematic review and meta-analysis. Front Endocrinol (Lausanne). 2023 Sep 26;14:1234761
• A Comparative Study Between Total Contact Cast and Pressure-Relieving Ankle Foot Orthosis in Diabetic Neuropathic Foot Ulcers; PP Chakraborty et al; Journal of Diabetes Science and Technology 2015, Vol. 9(2) 302 -308 © 2014

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department, Diabetology & Diabetic Foot, ILS Hospital, saltlake, Kolkata

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 8, 2025
• Study Start: January 4, 2023
• Primary Completion: June 29, 2023
• Study Completion: April 10, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

IN (1)