INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm | NCT07745764

NCT07745764

Overview

NCT ID: NCT07745764
Lead Sponsor: Barbara Wolff-WiniskiINDUSTRY
Official Title: INJECTHEAL- Profiling of Potential Wound Healing Therapeutics in Cellular Assays in the Presence of Wound Exudates
Brief 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)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Apr 10, 2028Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age ≥ 18 years

Type I or type II diabetes with lower extremity deep cavity ulcers

Arterial leg ulcers with lower extremity deep cavity ulcers

Surgical deep cavity non-healing wounds

Wounds with delayed healing

Routine treatment with negative pressure wound therapy

Routine sharp or surgical debridement

Sufficient wound exudate available (min. of 2 ml per visit)

Patient is informed about the study and has given informed consent

Exclusion Criteria:

Age ≤ 18 years

Multiple substance abuse (poly-toxicomania)

No signed declaration of consent or incapable of giving an informed written consent

Proven active infections with HIV, hepatitis C or HPV

Active pregnancy

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 72Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: Dr. med. Julian-Dario Rembe, Ph.D.Contact
julian-dario.rembe@med.uni-duesseldorf.de

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