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INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm

Not Yet RecruitingN/A

Sponsor: Barbara Wolff-Winiski

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

Interventions: standard of care

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (1)

Düsseldorf, Germany