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NCT03978234
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
Phase 2 trial testing AbobotulinumtoxinA 300 UNT in Plantar Fasciitis in 30 participants. Status unknown.
31 October 2021
Quick facts
| Lead sponsor | University Foot and Ankle Foundation |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 20 November 2019 |
| Primary completion | 31 October 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- AbobotulinumtoxinA 300 UNT — full drug profile →
Conditions studied
- Plantar Fasciitis — all drugs for Plantar Fasciitis →
- Plantar Fasciitis, Chronic — all drugs for Plantar Fasciitis, Chronic →
- Plantar Fasciitis of Both Feet — all drugs for Plantar Fasciitis of Both Feet →
Sponsor
University Foot and Ankle Foundation
Who can join
Adults 18 to 75, any sex, with Plantar Fasciitis or Plantar Fasciitis, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03978234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of AbobotulinumtoxinA 300 UNT
Trials testing the same drug.
- NCT06250543 — Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder · Phase 4 · completed
Other recruiting trials for Plantar Fasciitis
Currently open trials in the same condition.
- NCT07294196 — Percutaneous Electrolysis Targeting the Muscle-Fascia Chain for Treating Chronic Plantar Fasciitis in Adults · NA · recruiting
- NCT07463794 — Comparison of Extracorporeal Shock Wave Therapy and Whole Body Vibration Therapy in Plantar Fasciitis · NA · active not recruiting
- NCT07383558 — Effect of Additional Sural Nerve PRF in Chronic Heel Pain · recruiting
- NCT07242729 — Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Chronic Plantar Fasciitis · NA · recruiting
- NCT06967168 — HeEL Pain Pathways Feasibility Study · NA · recruiting
Other University Foot and Ankle Foundation trials
Trials by the same sponsor.
- NCT03254602 — Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis · NA · completed
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 NCT03978234 (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 Foot and Ankle Foundation
- Last refreshed: 24 September 2020
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/NCT03978234.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing