INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm

NCT07745764 · tracked via the Priya Life Science Germany tracker

Sponsor

Barbara Wolff-Winiski

Phase

Observational

Started

2026-08-01

Last updated

2026-08-04

Condition(s) studied

Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)

Investigational drug(s) / intervention(s)

standard of care

standard of care: Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts — Four weeks
Proliferation (Optical density)
Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples — Four weeks
Bacterial growth (Colony forming units)

Trial sites (1)

Facility	City	Region	Status
Heinrich-Heine University, Duesseldorf	Düsseldorf	Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07745764 on ClinicalTrials.gov ↗ ← All trials in Germany