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NCT04054076: Diab10
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
NA trial testing Prefabricated insoles in Diabetes in 224 participants. Completed in 31 December 2021.
31 January 2021
Quick facts
| Lead sponsor | Sahlgrenska University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 224 |
| Start date | 1 January 2020 |
| Primary completion | 31 January 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Prefabricated insoles
- Soft custom-made insoles
- Hard custom-made insoles
Conditions studied
- Diabetes — all drugs for Diabetes →
- Diabetic Foot — all drugs for Diabetic Foot →
- Plantar Ulcer — all drugs for Plantar Ulcer →
- Neuropathy — all drugs for Neuropathy →
Sponsor
Sahlgrenska University Hospital
Who can join
18 and older, any sex, with Diabetes or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure. The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI) . Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer. The primary aim of the study was to: explore gait characteristics, kinetics and kinematics in a cohort of patients diagnosed with diabetes, with and without neuropathy, assigned to use different types of insoles. The second aim was to assess the relation between gait characteristics, kinetics and kinematics to high plantar PP and PTI. The third aim was to compare gait characteristics, kinetics and kinematics of patients with diabetes and healthy controls.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04054076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04054076 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sahlgrenska University Hospital
- Last refreshed: 5 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04054076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing