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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 51 patients with plantar diabetic foot ulcer | Active Comparator | Total contact cast used for offloading the ulcer |
|
| 48 patients with plantar diabetic foot ulcer | Active Comparator | Posterior slab cast used for offloading the ulcer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total contact cast | Device | Arm with 51 patients was given total contact cast for offloading DFU |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measure was the rate of wound size reduction at 4 weeks and patient satisfaction. | 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). | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ILS Hoapital, Saltlake, Kolkata | Kolkata | West Bengal | 700064 | India |
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| Label | URL |
|---|---|
| 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 | View source |
| 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 | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 31, 2025 | Aug 5, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Posterior slab cast | Device | Arm with 48 patients were given posterior slab cast for offloading DFU |
|
| 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 | View source |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |