Last reviewed · How we verify
NCT07263945: TBAL
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Phase 1 trial testing As-prescribed prosthetic foot stiffness in Amputation in 60 participants. Currently enrolling.
31 May 2030
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 60 |
| Start date | 25 November 2025 |
| Primary completion | 31 May 2030 |
| Estimated completion | 31 May 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- As-prescribed prosthetic foot stiffness
- A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot
- A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot
Conditions studied
- Amputation — all drugs for Amputation →
- Transtibial Amputation - Unilateral — all drugs for Transtibial Amputation - Unilateral →
- Bone Anchored Devices — all drugs for Bone Anchored Devices →
- Osseointegration — all drugs for Osseointegration →
Sponsor
University of Colorado, Denver
Who can join
18 and older, any sex, with Amputation or Transtibial Amputation - Unilateral. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07263945
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Amputation
Currently open trials in the same condition.
- NCT07401966 — Amputations in Childhood and Neuropathic Pain · recruiting
- NCT07265154 — Gait Training and Artificial Intelligence · NA · recruiting
- NCT07347561 — A Comparison of Myoelectric and Bionic Hands · recruiting
- NCT07364266 — Analgesic Amputation for Algodystrophy: Feedback From a Case Series · active not recruiting
- NCT07044323 — Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment · NA · recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
- NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
- NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
- NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
- NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
- NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
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 NCT07263945 (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 of Colorado, Denver
- Last refreshed: 16 April 2026
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/NCT07263945.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing