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Sclerosing Agent

Sclerotherapy for Achilles Tendinopathy

Phase 2 & 3

Waitlist Available

Led By J Preston Wiley, MD, MPE

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults 18 years of age and older with a minimum of 3 months of clinically determinant history and symptoms (pain) consistent with unilateral Achilles tendinopathy (enthesitis or mid-portion) as diagnosed by a sport medicine physician

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Awards & highlights

Study Summary

This trial will test whether sclerotherapy is an effective treatment for Achilles tendinopathy for patients who have not responded to eccentric training.

Who is the study for?

This trial is for adults over 18 with chronic Achilles tendinopathy, who have tried a specific exercise program without success. It's not for professional athletes, those under 18, people with previous tendon ruptures or allergies to the treatment components, and anyone unable to do certain exercises.Check my eligibility

What is being tested?

The study tests if injecting a mix of dextrose and lidocaine (sclerotherapy) can help treat chronic Achilles tendinopathy in patients who haven't improved after following an exercise regimen.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, allergic reactions to the substances used (dextrose or lidocaine), and possibly temporary worsening of tendon pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with at least 3 months of Achilles tendon pain, diagnosed by a sports medicine doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Victorian Institute for Sport Assessment - Achilles

Secondary outcome measures

100 mm Visual Analog Scale

Number of Neovessels

Tegner Activity Scale

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 25% Dextrose and 1% LidocaineActive Control2 Interventions

Group II: LidocainePlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,137 Total Patients Enrolled

Sport Science Association of Alberta (SSAA)UNKNOWN

J Preston Wiley, MD, MPEPrincipal InvestigatorUniversity of Calgary

1 Previous Clinical Trials

48 Total Patients Enrolled

Media Library

25% Dextrose and 1% Lidocaine (Sclerosing Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00835939 — Phase 2 & 3

Achilles Tendinopathy Research Study Groups: 25% Dextrose and 1% Lidocaine, Lidocaine

Achilles Tendinopathy Clinical Trial 2023: 25% Dextrose and 1% Lidocaine Highlights & Side Effects. Trial Name: NCT00835939 — Phase 2 & 3

25% Dextrose and 1% Lidocaine (Sclerosing Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00835939 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can senior citizens participate in this research project?

"This particular clinical trial only enrolls individuals that are between 18-65 years old."

Answered by AI

Are there any eligibility requirements to participate in this research?

"This trial, which will have 17 patients in total, is looking for individuals that suffer from tendinitis and are of legal age (18 years or older)."

Answered by AI

What does the combination of 25% Dextrose and 1% Lidocaine typically help to alleviate?

"A 25% dextrose and 1% lidocaine solution is most often used to treat cervical syndrome but can also ameliorate conditions such as minor burns, transplantation, and osteoporosis."

Answered by AI

Is patient recruitment still ongoing for this experiment?

"Unfortunately, this research project is no longer looking for participants. The study was originally posted on September 1st, 2007 but the most recent update was February 3rd, 2009. If you are interested in other clinical trials, there are 83 trials for tendinitis and 135 for 25% Dextrose and 1% Lidocaine currently looking for patients."

Answered by AI

Are there published papers on the efficacy of 25% Dextrose and 1% Lidocaine?

"As of right now, 135 studies are underway that are looking into 25% Dextrose and 1% Lidocaine. Out of those, 34 studies are in Phase 3. Most of the research being conducted for 25% Dextrose and 1% Lidocaine is happening in Calgary, Alberta; but, there are 1,083 locations worldwide where these studies are taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment for Achilles Tendinopathy

2007. "Treatment for Achilles Tendinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00835939.

All > Lidocaine