Using a special shoe to treat diabetic foot ulcers
Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT
This study is testing a special sealed shoe to see if it helps people with diabetic foot ulcers heal better than traditional casts while still allowing them to walk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Örebro County Academic / other |
| Locations | 3 sites (Gothenburg and 2 other locations) |
| Trial ID | NCT04085926 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a sealed therapeutic shoe compared to traditional total contact casts (TCCs) for treating diabetic foot ulcers. The sealed shoe is designed to offload pressure from the ulcer while being non-removable, allowing for continuous wear. A total of 150 participants will be randomly assigned to receive either the sealed shoe or TCC, with assessments conducted by healthcare professionals to monitor ulcer healing, skin complications, and various health metrics over a year. The study aims to determine if the new shoe can improve outcomes while maintaining patient mobility.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with any type of diabetes who have a foot ulcer located under the metatarsal heads.
Not a fit: Patients with large ulcers, critical ischemia, uncontrolled infections, or certain foot deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance healing of diabetic foot ulcers while allowing patients to maintain their daily activities.
How similar studies have performed: While total contact casts are established in practice, the sealed therapeutic shoe represents a novel approach that has not been widely tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with diabetes mellitus (any kind) * Foot ulcer under metatarsal heads Exclusion Criteria: * large ulcer (3-5 metatarsal heads) * critical ischemia (defined as toe pressure \<30 mmHg or TcPO2 \<30 mmHg) * uncontrolled infection (IWGDF infection grade 4, or grade 3 if not treatment against infection has been administered) * Active Charcot foot * foot deformities that necessitate custom-made shoes * inability to speak/read Swedish. * People with increased risk that side-effects will not be discovered or reported (dementia, abuse of alcohol or drugs, intellectual disability, etc.) if the person do not have appropriate social support, will be excluded.
Where this trial is running
Gothenburg and 2 other locations
- Mölndahls sjukhus — Gothenburg, Sweden (Not_yet_recruiting)
- Skånes Universitetssjukhus, Malmö — Malmö, Sweden (Not_yet_recruiting)
- Örebro Universitetssjukhus — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Gustav Jarl, PhD — University Health Care Research Center, Region Örebro county
- Study coordinator: Gustav Jarl, PhD
- Email: gustav.jarl@regionorebrolan.se
- Phone: +46-19-6025875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.