ClinicalTrials.gg
CompletedNCT06396819Updated May 2, 2024

Collagen-povidone for Diabetic Seniors' Tenosynovitis

A Phase 4 interventional study of collagen-povidone solution in Diabetes Complications, sponsored by Instituto Mexicano del Seguro Social. Completed at 1 site in Mexico. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Instituto Mexicano del Seguro Social · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2023, registered Apr 2024).

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Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Diabetes Complications

Keywords

  • intervention
  • Stenosing Tenosynovitis
  • Collagen-Povidone
03

In context

Diabetes Complications

267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.

This study's enrollment of 25 is below the median of 72 across 171 interventional studies indexed under Diabetes Complications.

Browse Diabetes Complications studies →

Lead sponsor

Instituto Mexicano del Seguro Social is the lead sponsor of 126 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Adults aged 60 or older
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Therapeutic intervention using povidone collagen

    Drug: collagen-povidone solution

  • Placebo comparator
    Therapeutic intervention using placebo

    Drug: collagen-povidone solution

Interventions

  • Drugcollagen-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

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Mean evolution time of tenosynovitis

    Tenosynovitis should decreased its progression in the experimental group

    Time frame: 12 months

07

Study locations

1 site
  • 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
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Jan 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2024
First posted
May 2, 2024
StartActual
Jan 1, 2023
Primary completionActual
Jan 1, 2024
CompletionActual
Apr 1, 2024
Last update
May 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06396819
Responsible party
GONZALEZ-OJEDA ALEJANDRO (Principal Investigator, Instituto Mexicano del Seguro Social) — Principal investigator
First posted
May 2, 2024
Start date
Jan 1, 2023
Primary completion
Jan 1, 2024
Completion
Apr 1, 2024
Last update
May 2, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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