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NCT03046394: ProSto
Comparison Between Three Types of Prosthetic Feet
NA trial testing C-SACH in Amputation; Traumatic, Leg, Lower, Between Knee and Ankle in 1 participant. Completed in 3 May 2017.
10 February 2017
Quick facts
| Lead sponsor | University Rehabilitation Institute, Republic of Slovenia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | device feasibility |
| Enrollment | 1 |
| Start date | 6 February 2017 |
| Primary completion | 10 February 2017 |
| Estimated completion | 3 May 2017 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- C-SACH
- B-DER
- A-DER
Conditions studied
- Amputation; Traumatic, Leg, Lower, Between Knee and Ankle — all drugs for Amputation; Traumatic, Leg, Lower, Between Knee and Ankle →
Sponsor
University Rehabilitation Institute, Republic of Slovenia
Who can join
Adults 20 to 60, male only, with Amputation; Traumatic, Leg, Lower, Between Knee and Ankle. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.
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 NCT03046394
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other University Rehabilitation Institute, Republic of Slovenia trials
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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 NCT03046394 (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 University Rehabilitation Institute, Republic of Slovenia
- Last refreshed: 4 May 2017
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/NCT03046394.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing