INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
NCT07745764 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 72
Last updated 2026-08-04
Summary
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound biofilm/debridement material. Samples and routine clinical wound data will be used to test INJECTHEAL hydrogel components and other wound healing therapeutics, and identify molecular, biochemical, and microbiological biomarkers linked to wound healing.
Conditions
- Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
Interventions
- OTHER
-
standard of care
Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.
Sponsors & Collaborators
-
Heinrich-Heine University, Duesseldorf
collaborator OTHER -
Barbara Wolff-Winiski
lead INDUSTRY
Principal Investigators
-
Dr. Barbara Wolff-Winiski, MBA · Akribes/Biomedical GmbH, Dr. Bohr-Gasse 7 A-1030 Vienna, Austria
-
Dr. med. Julian-Dario Rembe, Ph.D. · Heinrich-Heine University, Duesseldorf; Moorenstr. 5 40225 Düsseldorf
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2028-04-10
- Completion
- 2028-04-10
Countries
- Germany
Study Locations
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