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NCT05351060
Novel Splinting Technique Using 3D Models
NA trial testing Custom Fabricated Splint in Arthritis in 10 participants. Status unknown.
15 July 2022
Quick facts
| Lead sponsor | Giovanna Fichera |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 10 |
| Start date | 16 May 2022 |
| Primary completion | 15 July 2022 |
| Estimated completion | 19 August 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Custom Fabricated Splint
Conditions studied
- Arthritis — all drugs for Arthritis →
- Osteoarthritis Hand — all drugs for Osteoarthritis Hand →
- Scleroderma, Systemic — all drugs for Scleroderma, Systemic →
- Scleroderma, Diffuse — all drugs for Scleroderma, Diffuse →
Sponsor
Giovanna Fichera
Who can join
Adults 18 to 100, any sex, with Arthritis or Osteoarthritis Hand. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to determine the feasibility of a non-contact custom splint fabrication method for patients with chronic diseases suffering from hypersensitive skin or compromised skin integrity. Custom splinting by occupational therapists involves molding low-temperature thermoplastic material directly on patients' skin; however, skin sensitivity is a contraindication for splint fabrication. The study aims to recruit 10 male or female patients with either a diagnosis of scleroderma (SSc) or arthritis. A scan of the patient's hand and a 3D printer will be used to create a precise model of a patient's hand on which a custom splint will be fabricated. By taking this approach, traditional splinting is substituted by avoiding direct contact with the material on the surface of the patient's upper extremity. This technique creates therapeutic opportunities for underserved patients by expanding splinting options for patients with scleroderma and arthritis, and addressing the challenges associated with managing chronic diseases.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05351060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05351060 (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 Giovanna Fichera
- Last refreshed: 28 April 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/NCT05351060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing