Status:
TERMINATED
Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers
Lead Sponsor:
Region Örebro County
Collaborating Sponsors:
Forte
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Total contact casts (TCCs) are effective treatment of plantar diabetic foot ulcers because they effectively offload the ulcer and are non-removable, resulting in high adherence to using the device. Ho...
Detailed Description
Data for the primary outcome of 112 participants are needed but the aim is to recruit 150, if possible within a reasonable time frame, to take drop-out into account. Participants are randomized (bloc...
Eligibility Criteria
Inclusion
- Diagnosed with diabetes mellitus (any kind)
- Foot ulcer under metatarsal heads
Exclusion
- 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.
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04085926
Start Date
January 16 2020
End Date
February 1 2022
Last Update
May 31 2025
Active Locations (3)
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1
Mölndahls sjukhus
Gothenburg, Sweden, SE-431 80
2
Skånes Universitetssjukhus, Malmö
Malmo, Sweden, SE-205 02
3
Örebro Universitetssjukhus
Örebro, Sweden, SE-70185