Suspended

IGF-IEffect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Insulin-like growth factor I

+ Placebo

Drug
Who is being recruted

Muscular Diseases+2

+ Musculoskeletal Diseases

+ Tendon Injuries

From 18 to 50 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorBispebjerg Hospital
Last updated: July 29, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up

NCT01834989
Principal SponsorBispebjerg Hospital
Last updated: July 29, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesTendinopathy

Criteria

3 inclusion criteria required to participate
anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
chronic patellar tendinopathy ( > 3 months)
hypo-echoic area with enhanced vascularization
6 exclusion criteria prevent from participating
Body mass index > 30
Diabetes
Knee operation
Knee osteoarthritis
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention

Group II

Placebo
3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Institute of Sports Medicine, Copenhagen

Copenhagen, DenmarkOpen Institute of Sports Medicine, Copenhagen in Google Maps
SuspendedOne Study Center