Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)INJECTHEALNCT07745764
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
An observational study of Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders), run by Barbara Wolff-Winiski at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2026to 10 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. med. Julian-Dario Rembe, Ph.D. contact
Germany1 site
Heinrich-Heine University, Duesseldorf
Düsseldorf, 40225
Dr. med. Julian-Dario Rembe, Ph.D., +49 211 81 - 07163, julian-dario.rembe@med.uni-duesseldorf.de
Dr. med. Julian-Dario Rembe, Ph.D.
About this study
Official title: INJECTHEAL- Profiling of Potential Wound Healing Therapeutics in Cellular Assays in the Presence of Wound Exudates
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.
Read the detailed description
The Horizon Europe project INJECTHEAL platform is designed to provide a biomimetic matrix for tissue regeneration and to enable controlled delivery of antibacterial, anti-inflammatory, and pro-angiogenic components.
This is a monocentric, prospective, exploratory, non-interventional observational study. It involves the collection of biological material and health-related personal data from adults with chronic, non-healing deep cavity wounds who are treated as part of routine clinical care. Study data will be documented in doubly pseudonymized form.
Biological material will consist of routine clinical waste material. Wound exudate will be obtained from negative pressure wound therapy and biofilm/debridement material will be collected from medically indicated sharp or surgical debridement. Where feasible, longitudinal sampling will be performed during routine wound care visits, with approximately 3 to 5 visits expected per participant.
Components of the INJECTHEAL hydrogel system and other wound healing therapeutics will be evaluated for their capacity to mitigate or reverse inhibitory effects of chronic wound material on regenerative cellular functions.
Further analyses will include biochemical and molecular characterization of wound exudates, including total protein, proteases and protease activity, growth factors, cytokines, proteomic profiles, and metabolomic profiles. Biofilm samples will be analyzed using microbiological and molecular methods, including bacterial rRNA16S metagenomic sequencing and patient-specific 3D biofilm models to assess antibacterial effects of INJECTHEAL components.
- Being tested
- standard of care
- 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
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic wounds | Not described Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts
Proliferation (Optical density)
Measured: Four weeks
Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples
Bacterial growth (Colony forming units)
Measured: Four weeks
Secondary outcomes (11)
Effects of Wound Material and Test Substances on Cell Migration
Cellular migration (Percent surface area covered)
Measured: Four weeks
Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types
Proliferation (Optical density)
Measured: Four weeks
Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types
Measurement of pro-inflammatory cytokines (ng/ml)
Measured: Four weeks
Protein content of wound exudate
Quantification of total protein (mg/ml)
Measured: Four weeks
Proteomics profile of wound exudate
Proteomics analysis of wound exudate (-log10(p-value))
Measured: Four months
Bacterial composition of wound biofilm by rRNA16S sequencing
Bioburden, Diversity and Pathogens
Measured: Four weeks
Correlation of ex vivo/in vitro, biochemical, proteomic, metabolomic, and microbiological findings with routinely collected clinical data
Correlation of laboratory findings with clinical wound trajectory
Measured: Four weeks
Effects of Wound Material and Test Substances on Extracellular Matrix Formation
Extracellular Matrix Formation (Optical density)
Measured: 4 weeks
Inflammatory Marker Response in Wound-Relevant Cell Types
Inflammatory markers (Mean fluorescence intensity)
Measured: 4 weeks
Metabolomics profile of wound exudate
Metabolomics analysis of wound exudate (Ion counts)
Measured: 4 months
Protease acitivty
Proteases (nM)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion10 Apr 2028 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Wolff-Winiski
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Responsible party
- Sponsor-investigator, Barbara Wolff-Winiski, Akribes Biomedical GmbH
- Investigators
- Dr. Barbara Wolff-Winiski, MBA, Study director, Akribes/Biomedical GmbH, Dr. Bohr-Gasse 7 A-1030 Vienna, AustriaDr. med. Julian-Dario Rembe, Ph.D., Principal investigator, Heinrich-Heine University, Duesseldorf; Moorenstr. 5 40225 Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745764
- Sponsor's protocol ID
- INJECTHEAL-01
- Other IDs
- 2026-3666
- Acronym
- INJECTHEAL
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data can be shared anonymized upon contact with PI, after publication of primary results.
Publications
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.
PubMed 26979354Doerfler 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.
PubMed 38960086Falanga 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.
PubMed 35864102Sen 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.
PubMed 19903300Versey 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.
PubMed 33897696
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INJECTHEAL- Profiling of Potential Wound Healing Therapeutics in Cellular Assays in the Presence of Wound Exudates
- ClinicalTrials.gov ID
- NCT07745764
- Acronym / sponsor ID
- INJECTHEAL / INJECTHEAL-01
- Keywords
- Chronic Wound, Non-healing Wound, Wound healing, Wound Exudate, Wound Biofilm, Wound Microbiome, Fibroblast proliferation, Negative pressure wound therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Barbara Wolff-WiniskiIndustry (pharma, biotech, devices)
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 10 Apr 2028 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Horizon Europe project INJECTHEAL platform is designed to provide a biomimetic matrix for tissue regeneration and to enable controlled delivery of antibacterial, anti-inflammatory, and pro-angiogenic components.
This is a monocentric, prospective, exploratory, non-interventional observational study. It involves the collection of biological material and health-related personal data from adults with chronic, non-healing deep cavity wounds who are treated as part of routine clinical care. Study data will be documented in doubly pseudonymized form.
Biological material will consist of routine clinical waste material. Wound exudate will be obtained from negative pressure wound therapy and biofilm/debridement material will be collected from medically indicated sharp or surgical debridement. Where feasible, longitudinal sampling will be performed during routine wound care visits, with approximately 3 to 5 visits expected per participant.
Components of the INJECTHEAL hydrogel system and other wound healing therapeutics will be evaluated for their capacity to mitigate or reverse inhibitory effects of chronic wound material on regenerative cellular functions.
Further analyses will include biochemical and molecular characterization of wound exudates, including total protein, proteases and protease activity, growth factors, cytokines, proteomic profiles, and metabolomic profiles. Biofilm samples will be analyzed using microbiological and molecular methods, including bacterial rRNA16S metagenomic sequencing and patient-specific 3D biofilm models to assess antibacterial effects of INJECTHEAL components.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic wounds | – | Other: standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of carePatients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit. | Other | Patients with chronic wounds |
Primary outcome
Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts
Time frame: Four weeks
Proliferation (Optical density)
Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples
Time frame: Four weeks
Bacterial growth (Colony forming units)
11 secondary outcomes
Effects of Wound Material and Test Substances on Cell Migration
Time frame: Four weeks
Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types
Time frame: Four weeks
Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types
Time frame: Four weeks
Protein content of wound exudate
Time frame: Four weeks
Proteomics profile of wound exudate
Time frame: Four months
Bacterial composition of wound biofilm by rRNA16S sequencing
Time frame: Four weeks
Correlation of ex vivo/in vitro, biochemical, proteomic, metabolomic, and microbiological findings with routinely collected clinical data
Time frame: Four weeks
Effects of Wound Material and Test Substances on Extracellular Matrix Formation
Time frame: 4 weeks
Inflammatory Marker Response in Wound-Relevant Cell Types
Time frame: 4 weeks
Metabolomics profile of wound exudate
Time frame: 4 months
Protease acitivty
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 26979354Alavi 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.
- Background: PubMed 38960086Doerfler 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.
- Background: PubMed 35864102Falanga 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.
- Background: PubMed 19903300Sen 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.
- Background: PubMed 33897696Versey 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.
- Individual participant dataSharing planned: Yes. Individual patient data can be shared anonymized upon contact with PI, after publication of primary results.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. med. Julian-Dario Rembe, Ph.D. contact
Dr. Barbara Wolff-Winiski, MBA study director
Akribes/Biomedical GmbH, Dr. Bohr-Gasse 7 A-1030 Vienna, Austria
Dr. med. Julian-Dario Rembe, Ph.D. principal investigator
Heinrich-Heine University, Duesseldorf; Moorenstr. 5 40225 Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders), run by Barbara Wolff-Winiski at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. med. Julian-Dario Rembe, Ph.D. (+49 211 81 - 07163, julian-dario.rembe@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07745764, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.