NCT05844930

A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder

Double Blinded Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) vs. Standard of Care in Adhesive Capsulitis of the Shoulder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare ActiveMatrix® to standard of care corticosteroid injection in the treatment of adhesive capsulitis of the shoulder (frozen shoulder).

Conditions

• Adhesive Capsulitis

Interventions

Type	Name	Description
DRUG	Corticosteroid	Triamcinolone 20 mg (1cc)
OTHER	ActiveMatrix	1cc ActiveMatrix (Skye Biologics, Inc.)
DRUG	Lidocaine	Lidocaine 10 mg/mL (5cc)

Timeline

• Start date: 2023-01-03
• Primary completion: 2025-02-04
• Completion: 2025-02-04
• First posted: 2023-05-06
• Last updated: 2026-03-05
• Results posted: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study