Is a more comfortable cast available for diabetic foot wounds? A follow-up cohort study
| ISRCTN | ISRCTN16824836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16824836 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | M19.230293, NTR6142 |
| Sponsor | University Medical Center Groningen |
| Funder | ChiCoN BV, chirurgen coöperatie Noord-Nederland |
- Submission date
- 05/12/2021
- Registration date
- 08/12/2021
- Last edited
- 12/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
A diabetic foot ulcer (DFU) is often cured and prevented by a cast with off-loading (minimizing or removing weight placed on the foot to help prevent and heal ulcers).
Unfortunately, a cast is a nuisance for a patient, because of its irremovable properties. Because of its' stiffness, patients are not able to walk comfortably.
The newer, non-removable total contact softcast (TCS) is easy in its application and comfortable to walk upon.
Healing in patients given the TCS are compared to a cohort of patients treated with a non-removable total contact cast (TCC).
Who can participate?
Data from patients who received treatment for a DFU using one of the two types of cast between 2010 and 2017 were included.
What does the study involve?
Patients treated with a TCC are compared to patients treated with a TCS. Wounds are evaluated weekly at the hospital.
What are the possible benefits and risks of participating?
None
Where is the study run from?
The study is run from the Wilhelmina Ziekenhuis Assen and supported by the University Medical Centre of Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
May 2015 to June 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr B.P. Vierhout, Bas.Vierhout@WZA.NL
Contact information
Scientific
Nicolaas Beetslaan 35
Assen
9405BC
Netherlands
 ORCID ID |
0000-0001-8381-0479 |
|---|---|
| Phone | +31 (0)629601484 |
| bas.vierhout@wza.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Non-removable total contact cast vs non-removable total contact softcast in diabetic foot ulcers |
| Study objectives | A total contact softcast (TCS) heals as many diabetic foot ulcers (DFU) when compared to a classic total contact cast (TCC). |
| Ethics approval(s) | Approved 29/05/2018, University Medical Ethical Committee of the University Medical Center of Groningen (P.O.Box 30 001, 9700RB Groningen, Netherlands; +31 503614204; metc@umcg.nl), ref: M19.230293 |
| Health condition(s) or problem(s) studied | Diabetic foot ulcer |
| Intervention | Patients with a plantar DFU were treated with a TCC or a TCS and followed for 6 months to evaluate the healing of the DFU. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Percentage of patients with complete ulcer healing within 6 months after the start of treatment with a cast measured using patient records |
| Key secondary outcome measure(s) |
Time to healing (days) measured using patient records |
| Completion date | 01/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 61 |
| Key inclusion criteria | 1. Diabetic patient 2. Open diabetic foot ulcer 3. Ulcer at the plantar part of the foot 4. Neuropathic ulcer |
| Key exclusion criteria | 1. Diabetic without an ulcer 2. Ischemic ulcer 3. Compliance issues |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/01/2018 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Assen
9401RK
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available upon request from BP Vierhout (bas.vierhout@wza.nl). Data will be available during 2022 to research teams with obvious interest for the techniques used in the publication. Data will remain anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/08/2022 | 12/08/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/08/2022: Publication reference added.
08/12/2021: Trial's existence confirmed by University Medical Ethical Committee of the University Medical Center of Groningen.
