Diabetic Foot Ulcer (DFU)NCT07111741
Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers
A study testing Total contact cast and Posterior slab cast in people with Diabetic Foot Ulcer (DFU) and Offloading, run by ILS Hospital, Salt Lake at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Offloading
- What is being tested?
- Total contact cast and Posterior slab cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteIndia
- Study dates
- 4 Jan 2023to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with diabetes
- a single neuropathic plantar DFU
- Ulcer belonging to Wagner grade 2 and 3
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers: a Randomized Controlled Trial
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.
Read more
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
- Being tested
- Total contact cast, Posterior slab cast
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total contact castDevice
Arm with 51 patients was given total contact cast for offloading DFU
Posterior slab castDevice
Arm with 48 patients were given posterior slab cast for offloading DFU
| Study group | Role | What they receive |
|---|---|---|
| 51 patients with plantar diabetic foot ulcer | Active comparator | Total contact cast used for offloading the ulcer Receives: Device: Total contact cast |
| 48 patients with plantar diabetic foot ulcer | Active comparator | Posterior slab cast used for offloading the ulcer Receives: Device: Posterior slab cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start4 Jan 2023
- Primary completion29 Jun 2023
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- ILS Hospital, Salt Lake
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghanshyam Goyal, ILS Hospital, Salt Lake
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111741
- Sponsor's protocol ID
- ILSS/EC/0012-DFU/2022
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07111741
- Acronym / sponsor ID
- ILSS/EC/0012-DFU/2022
- Conditions
- Diabetic Foot Ulcer (DFU), Offloading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- ILS Hospital, Salt LakeUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 51 patients with plantar diabetic foot ulcer | Active comparator | Device: Total contact castTotal contact cast used for offloading the ulcer |
| 48 patients with plantar diabetic foot ulcer | Active comparator | Device: Posterior slab castPosterior slab cast used for offloading the ulcer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People with diabetes
- a single neuropathic plantar DFU
- Ulcer belonging to Wagner grade 2 and 3
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total contact castArm with 51 patients was given total contact cast for offloading DFU | Device | 51 patients with plantar diabetic foot ulcer |
| Posterior slab castArm with 48 patients were given posterior slab cast for offloading DFU | Device | 48 patients with plantar diabetic foot ulcer |
Primary outcome
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.
1 secondary outcome
The secondary outcome measure was the rate of wound size reduction at 4 weeks and patient satisfaction.
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- 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/jfa2.70001Link provided by the sponsor.
- 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;14:1234761Link provided by the sponsor.
- 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 © 2014Link provided by the sponsor.
Related trials for Diabetic Foot Ulcer (DFU)
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Active, not recruiting
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
Diabetic Foot Ulcer (DFU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total contact cast and Posterior slab cast in people with Diabetic Foot Ulcer (DFU) and Offloading, run by ILS Hospital, Salt Lake at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure in this study was healing of the ulcer at 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.