INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm

NCT07745764 | Not Yet Recruiting

• 2 other identifiers: INJECTHEAL-012026-3666
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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)

Keywords

Chronic Wound; Non-healing Wound; Wound healing; Wound Exudate; Wound Biofilm; Wound Microbiome; Fibroblast proliferation; Negative pressure wound therapy; rRNA 16S; Deep cavity wounds; Hydrogel

Outcome Measures

Primary Outcomes (2)

• Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts

  Proliferation (Optical density)

  Four weeks

• Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples

  Bacterial growth (Colony forming units)

  Four weeks

Secondary Outcomes (11)

• Effects of Wound Material and Test Substances on Cell Migration

  Four weeks

• Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types

  Four weeks

• Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types

  Four weeks

• Protein content of wound exudate

  Four weeks

• Proteomics profile of wound exudate

  Four months

Study Arms (1)

Patients with chronic wounds

Other: standard of care

Interventions

standard of care OTHER

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

Patients with chronic wounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic, non-healing deep cavity wounds, such as diabetic foot ulcers, arterial ulcers of the lower extremity, post-surgical non-healing wounds, or wounds with delayed healing, who are treated as part of routine clinical care and who undergo routine negative pressure wound therapy and/or medically indicated sharp or surgical debridement.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Wolff-Winiski: lead
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

Heinrich-Heine University, Duesseldorf

Düsseldorf, 40225, Germany

Location

Related Publications (5)

• Alavi A, Sibbald RG, Phillips TJ, Miller OF, Margolis DJ, Marston W, Woo K, Romanelli M, Kirsner RS. What's new: Management of venous leg ulcers: Approach to venous leg ulcers. J Am Acad Dermatol. 2016 Apr;74(4):627-40; quiz 641-2. doi: 10.1016/j.jaad.2014.10.048.

  PMID: 26979354 BACKGROUND

• Doerfler P, Schoefmann N, Cabral G, Bauer W, Berli MC, Binder B, Borst C, Botter S, French LE, Goerge T, Hafner J, Hartmann D, Hogh A, Hoetzenecker W, Holzer-Geissler JCJ, Kamolz LP, Kofler K, Luger T, Nischwitz SP, Popovits M, Rappersberger K, Restivo G, Schlager JG, Schmuth M, Stingl G, Stockinger T, Stroelin A, Stuetz A, Umlauft J, Weninger WP, Wolff-Winiski B. Development of a Cellular Assay as a Personalized Model for Testing Chronic Wound Therapeutics. J Invest Dermatol. 2025 Mar;145(3):631-644.e22. doi: 10.1016/j.jid.2024.05.029. Epub 2024 Jul 1.

  PMID: 38960086 BACKGROUND

• Falanga V, Isseroff RR, Soulika AM, Romanelli M, Margolis D, Kapp S, Granick M, Harding K. Chronic wounds. Nat Rev Dis Primers. 2022 Jul 21;8(1):50. doi: 10.1038/s41572-022-00377-3.

  PMID: 35864102 BACKGROUND

• Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.

  PMID: 19903300 BACKGROUND

• Versey Z, da Cruz Nizer WS, Russell E, Zigic S, DeZeeuw KG, Marek JE, Overhage J, Cassol E. Biofilm-Innate Immune Interface: Contribution to Chronic Wound Formation. Front Immunol. 2021 Apr 9;12:648554. doi: 10.3389/fimmu.2021.648554. eCollection 2021.

  PMID: 33897696 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Wound exudate obtained from negative pressure wound therapy containers or sponges; wound biofilm/debridement material retained from medically indicated sharp or surgical debridement. Samples are processed, doubly pseudonymized, stored at -80°C, and shipped on dry ice to project partners. No human genetic analyses are planned; bacterial rRNA16S sequencing will be performed to characterize wound biofilm composition.

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dr. Barbara Wolff-Winiski, MBA

  Akribes/Biomedical GmbH, Dr. Bohr-Gasse 7 A-1030 Vienna, Austria

  STUDY DIRECTOR

• Dr. med. Julian-Dario Rembe, Ph.D.

  Heinrich-Heine University, Duesseldorf; Moorenstr. 5 40225 Düsseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. med. Julian-Dario Rembe, Ph.D.

CONTACT

+49 211 81 - 07163‬‬‬‬‬‬‬‬‬‬‬‬; julian-dario.rembe@med.uni-duesseldorf.de

Dr. Barbara Wolff-Winiski, MBA

CONTACT

+43 1 226 2022 02; barbara.wolff-winiski@akribes-biomedical.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Scientific Officer

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 10, 2028
• Study Completion (Estimated): April 10, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be avaiable after publication of primary results.
• Access Criteria: Access upon request via email to Principal Investigator.

Locations

DE (1)