Collagen-povidone for Diabetic Seniors' Tenosynovitis

NCT06396819 | Completed Phase 4

• 1 other identifier: Collagen-Polyvidone-24
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Complications

Keywords

intervention; Stenosing Tenosynovitis; Collagen-Povidone

Outcome Measures

Primary Outcomes (1)

• Mean evolution time of tenosynovitis

  Tenosynovitis should decreased its progression in the experimental group

  12 months

Study Arms (2)

Therapeutic intervention using povidone collagen

EXPERIMENTAL

Drug: collagen-povidone solution

Therapeutic intervention using placebo

PLACEBO COMPARATOR

Drug: collagen-povidone solution

Interventions

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

Also known as: Placebo

Therapeutic intervention using placebo; Therapeutic intervention using povidone collagen

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Adults aged 60 or older

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Diabetes Complications; Tendon Entrapment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A therapeutic intervention using povidone collagen vs. placebo was carried out, and the patients were recruited after meeting the inclusion criteria and divided into two randomized groups (Case vs Control). Application of collagen-povidone solution at a dose of 0.2 cc, compared with the application of physiological solution in the control group.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

ME (1)