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NCT06396819 Clinical Trial

Collagen-povidone for Diabetic Seniors' Tenosynovitis

Diabetes Complications Clinical Trial

Official title:
Topical Collagen-povidone Injection as an Alternative Treatment for Stenosing Tenosynovitis in Older Adults With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06396819
Other study ID # Collagen-Polyvidone-24
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2023
Est. completion date April 1, 2024

Study information
Verified date April 2024
Source Instituto Mexicano del Seguro Social
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Diabetes affects 415 million adults globally, leading to hand issues. Povidone collagen shows promise in managing tenosynovitis. A clinical trial was conduced to compared its efficacy in adults over 60. It is shown that the intervention reduces pain, improves functionality, and grip strength with no complications. Collagen povidone holds potential for treating diabetic hand issues.

Description:

A randomized clinical trial from January 2022 to January 2023 compared povidone collagen intervention with a placebo in adults aged 60 and above suffering from stenosing tenosynovitis. Participants were randomized into Case (collagen-povidone) and Control (physiological solution) groups. The study evaluated parameters like tenosynovitis, diabetes, pain, functionality, and grip strength.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date April 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Diagnostic of stenosing tenosynovitis - Diagnostic of diabetes - Adults aged 60 or older Exclusion Criteria: - Adults aged 60 or older

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• collagen-povidone solution
Application of collagen-povidone solution at a dose of 0.2 cc, compared with the application of physiological solution in the control group

Locations
Country Name City State
Mexico Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico Guadalajara Jalisco

Sponsors (1)
Lead Sponsor Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean evolution time of tenosynovitis Tenosynovitis should decreased its progression in the experimental group 12 months
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