Chronic WoundsDFUBiofilmNCT05172089
Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
An observational study of Chronic Wounds and Biofilm Infection, run by University of Pittsburgh at 2 sites in United States.
Trial summary
This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds, Biofilm Infection, Trans-epidermal Water Loss (TEWL)
- How many people
- 405 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2024to 27 Jun 2029
- 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: clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited for this larger cohort of patients in the parent study.
Who may be able to join
- Male or Female, Age ≥ 18
- Willing to comply with protocol instructions, including all study visits and study activities.
- Patient with an open Diabetic Foot Ulcer
- Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):
- TcOM >30 mmHg
- Ankle-brachial index at least ≥0.7
- Toe pressure > 30 mmHg
- TBI > 0.6 mmHg
Who cannot join
- Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.
- Wounds closed or to be surgically closed by flap or graft coverage
- Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications.
- TcOM < 30mmHg
- Diabetics with a hemoglobin A1c > 15 within 3 months prior to enrollment
- Subject with autoimmune connective tissue disease
Show all 10Show fewer
- Ulcer size and location that does not allow the TEWL measurement per SOP
- Pregnant women
- Prisoners
- Unable to comply with study procedures and/or complete study visits
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UPMC Wound Healing Services at UPMC Passavant
Cranberry Township, Pennsylvania, 16066
Chandan K Sen, Phd
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Fleur Maturo, 520-621-8296, fleurmartinez@arizona.edu
Geoffrey C. Gurtner, MD
About this study
This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.
Read the detailed description
Diabetic foot ulcers (DFU) are one of the most common reasons for hospitalization of diabetic patients and frequently results in amputation of lower limbs. Of the one million people who undergo non-traumatic leg amputations annually worldwide, 75% are performed on people who have type 2 diabetes (T2DM). The risk of death at 10 years for a diabetic with DFU is twice as high as the risk for a patient without a DFU. The rate of amputation in patients with DFU is 38.4%4. Infection is a common (>50%) complication of DFU. Emerging evidence underscores the significant risk that biofilm infection poses to the non-healing DFU. Biofilms are estimated to account for 60% of chronic wound infections. In the biofilm form, bacteria are in a dormant metabolic state. Thus, standard clinical techniques like the colony forming unit (CFU) assay to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent maleficent threat in wound care.
n the current standard of care (SoC), wound closure is defined (FDA) by wound area re-epithelialization without drainage. The investigators' pre-clinical large animal work demonstrates that wounds with a history of biofilm infection may meet above criteria, but the repaired wound-site skin is deficient in barrier function. This has led to the concept of functional wound closure wherein the current clinical definition of wound closure is supplemented with a functional parameter - restoration of skin barrier function as measured by low trans-epidermal water loss (TEWL).
This study rests pilot study showing that closed DFU with deficient barrier function are more likely to recur. Biofilm infection as assessed through scanning electron microscopy and wheat germ agglutin assay performed on debrided tissue causes faulty re-epithelialization, compromising skin barrier function at the closed wound site. This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.
- Conditions
- Chronic Wounds, Biofilm Infection, Trans-epidermal Water Loss (TEWL), Diabetic Foot, Diabetic Foot Infection
- Keywords
- foot ulcer, diabetic foot, wound infection, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Foot Ulcer study | 405 clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited . Wound swab for culture obtained. Baseline digital imaging of target wound(s). SF-12 Health survey, Visual Analogue Pain scale, Cardiff wound impact questionnaires. Wound site evaluation including TcOM/TBI/ankle brachial index (ABI) will be completed for subjects with wounds below the knee, if not already completed per standard of care within the previous 12 months. Hemoglobin A1c point of care testing will be drawn for diabetic subjects who do not have an A1c available within 90 days prior to enrollment; 3mm biopsy tissue or debrided tissue will be collected. Ideally, two tissue samples will be obtained; the subject's medical records will be reviewed and followed for up to 16 weeks or until their wound has closed, whichever comes first. The research staff will also call the patient or care facility as needed to check for wound closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biofilm infection abundance
Test the incidence of wound biofilm infection at initial visit and test its association with deficient skin barrier function at the closed DFU-site
Measured: 16 weeks
TEWL
Trans epidermal water loss post closure and 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start2 Apr 2024
- Primary completion27 Jun 2028 (estimated)
- Study completion27 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Arizona
- Responsible party
- Principal investigator, Chandan Sen, University of Pittsburgh
- Investigators
- Chandan K Sen, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172089
- Sponsor's protocol ID
- STUDY23050116
- Other IDs
- 3R01DK125835-02S1
- Acronym
- DFUBiofilm
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
- ClinicalTrials.gov ID
- NCT05172089
- Acronym / sponsor ID
- DFUBiofilm / STUDY23050116
- Conditions
- Chronic Wounds, Biofilm Infection, Trans-epidermal Water Loss (TEWL), Diabetic Foot, Diabetic Foot Infection
- Keywords
- foot ulcer, diabetic foot, wound infection, diabetic foot ulcer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Arizona
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 27 Jun 2028 (estimated)
- Study completion
- 27 Jun 2029 (estimated)
- First posted
- 29 Dec 2021 (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 work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.
Detailed description
Diabetic foot ulcers (DFU) are one of the most common reasons for hospitalization of diabetic patients and frequently results in amputation of lower limbs. Of the one million people who undergo non-traumatic leg amputations annually worldwide, 75% are performed on people who have type 2 diabetes (T2DM). The risk of death at 10 years for a diabetic with DFU is twice as high as the risk for a patient without a DFU. The rate of amputation in patients with DFU is 38.4%4. Infection is a common (>50%) complication of DFU. Emerging evidence underscores the significant risk that biofilm infection poses to the non-healing DFU. Biofilms are estimated to account for 60% of chronic wound infections. In the biofilm form, bacteria are in a dormant metabolic state. Thus, standard clinical techniques like the colony forming unit (CFU) assay to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent maleficent threat in wound care.
n the current standard of care (SoC), wound closure is defined (FDA) by wound area re-epithelialization without drainage. The investigators' pre-clinical large animal work demonstrates that wounds with a history of biofilm infection may meet above criteria, but the repaired wound-site skin is deficient in barrier function. This has led to the concept of functional wound closure wherein the current clinical definition of wound closure is supplemented with a functional parameter - restoration of skin barrier function as measured by low trans-epidermal water loss (TEWL).
This study rests pilot study showing that closed DFU with deficient barrier function are more likely to recur. Biofilm infection as assessed through scanning electron microscopy and wheat germ agglutin assay performed on debrided tissue causes faulty re-epithelialization, compromising skin barrier function at the closed wound site. This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Foot Ulcer study | – | –405 clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited . Wound swab for culture obtained. Baseline digital imaging of target wound(s). SF-12 Health survey, Visual Analogue Pain scale, Cardiff wound impact questionnaires. Wound site evaluation including TcOM/TBI/ankle brachial index (ABI) will be completed for subjects with wounds below the knee, if not already completed per standard of care within the previous 12 months. Hemoglobin A1c point of care testing will be drawn for diabetic subjects who do not have an A1c available within 90 days prior to enrollment; 3mm biopsy tissue or debrided tissue will be collected. Ideally, two tissue samples will be obtained; the subject's medical records will be reviewed and followed for up to 16 weeks or until their wound has closed, whichever comes first. The research staff will also call the patient or care facility as needed to check for wound closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited for this larger cohort of patients in the parent study.
Key inclusion criteria (8 listed)
- Male or Female, Age ≥ 18
- Willing to comply with protocol instructions, including all study visits and study activities.
- Patient with an open Diabetic Foot Ulcer
- Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):
- TcOM >30 mmHg
Key exclusion criteria (10 listed)
- Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.
- Wounds closed or to be surgically closed by flap or graft coverage
- Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications.
- TcOM < 30mmHg
- Diabetics with a hemoglobin A1c > 15 within 3 months prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biofilm infection abundance
Time frame: 16 weeks
Test the incidence of wound biofilm infection at initial visit and test its association with deficient skin barrier function at the closed DFU-site
TEWL
Time frame: 12 weeks
Trans epidermal water loss post closure and 12 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 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Chandan K Sen, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Wounds and Biofilm Infection, run by University of Pittsburgh at 2 sites in United States.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Piya Das Ghatak, PhD, MS (4126240422, piya.dasghatak@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm infection abundance (time frame: 16 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?
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 18 Mar 2026.