Collagen-povidone for Diabetic Seniors' Tenosynovitis

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.

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Key information

Conditions

Diabetes Complications Diabetes Mellitus Endocrine System Diseases Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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, 44329, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnostic of stenosing tenosynovitis
Diagnostic of diabetes
Adults aged 60 or older

Exclusion criteria

Adults aged 60 or older

Treatment and study plan

collagen-povidone solution

Drug

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

Other names: Placebo

Primary outcomes

Mean evolution time of tenosynovitis

Time frame: 12 months

Tenosynovitis should decreased its progression in the experimental group

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 2, 2024
Registry last updated: May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed