INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm (NCT07745764) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
Germany72 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts
Timeframe: Four weeks
2
Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples