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Viscosupplementation

Gel-One for Anterior Cruciate Ligament (ACL) (HEALR Trial)

Phase < 1
Waitlist Available
Research Sponsored by Cale Jacobs, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
14-33 years of age
Currently participating in a sporting activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

HEALR Trial Summary

This trial will help researchers learn more about why ACL injuries lead to knee pain and disability, and whether or not Gel-One can help relieve that pain.

Eligible Conditions
  • Anterior Cruciate Ligament (ACL)

HEALR Trial Eligibility Criteria

Inclusion Criteria

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

HEALR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in KOOS score over time
Secondary outcome measures
Change in CTX-II pre and post surgery
Other outcome measures
MRIT1rho measurement of articular cartilage
Number of participants with adverse events that are related to treatment.

Side effects data

From undefined Phase 3 trial • 332 Patients • NCT01240382
1%
Eye irritation
1%
Gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.1% HA
3% DE-089

HEALR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 - Gel-OneExperimental Treatment1 Intervention
Gel-One (3ml/30 mg Hyaluronan) one time injection at visit 3
Group II: Group 1 - Saline PlaceboPlacebo Group1 Intervention
3 ml saline placebo one time injection at visit 3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gel-One
2017
Completed Early Phase 1
~840

Find a Location

Who is running the clinical trial?

Cale Jacobs, PhDLead Sponsor
4 Previous Clinical Trials
114 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions
Cale Jacobs, PhD 2017. "Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03429140.
~3 spots leftby Apr 2025
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