Diabetic Foot Ulcer Recurrence: Pilot Study (DFUCO)
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| ClinicalTrials.gov Identifier: NCT03479242 |
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Recruitment Status :
Recruiting
First Posted : March 27, 2018
Last Update Posted : April 7, 2020
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| Tracking Information | |||||||||
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| First Submitted Date | January 25, 2018 | ||||||||
| First Posted Date | March 27, 2018 | ||||||||
| Last Update Posted Date | April 7, 2020 | ||||||||
| Actual Study Start Date | January 25, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Functional skin closure in DFU in relation to biofilm infection [ Time Frame: 7 months ] TEWL will be measured to check for functional wound closure and see if DFU recidivism is high in subjects with a history of biofilm infection
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| Original Primary Outcome Measures |
Functional skin closure in DFU in relation to biofilm infection [ Time Frame: 4 months ] TEWL will be measured to check for functional wound closure and see if DFU recidivism is high in subjects with a history of biofilm infection
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Diabetic Foot Ulcer Recurrence: Pilot Study | ||||||||
| Official Title | To Study Diabetic Foot Ulcer Recurrence With Trans Epidermal Water Loss Measured With Derma Lab | ||||||||
| Brief Summary | In this prospective pilot study, patients with DFU visiting the Ohio State University Comprehensive Wound Center will be enrolled. Patients enrolled in the study will be followed for 16 weeks for wound closure(Phase A), and will then begin Phase B where TEWL measurements and wound recurrence will be followed up for up to 12 weeks. | ||||||||
| Detailed Description | Diabetes impairs immune defenses such that the ability to fight wound infection is weakened. Thus, infection is a major problem in diabetic foot ulcers (DFUs) . Biofilms are estimated to account for 60% of chronic wound infections6. In biofilm bacteria are encased within extra polymeric substance (EPS) and become recalcitrant to antimicrobials and host defenses.In the biofilm form, bacteria may not form colony. Thus, standard clinical techniques like CFU to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent threat in wound care. Using a preclinical swine model of mixed species wound biofilm infection, we struck an unusual observation. Although biofilm infection may or may not influence the rate of wound closure as measured by standard planimetry, it inevitably compromises the functional property of the repaired skin. The wound may close as evaluated visually, but that closed wound lacks barrier function. Such pathology is caused by the perturbation of epithelial junctional proteins in response to biofilm infection. While detecting the biofilm directly is readily not possible at present in the wound clinics, compromised barrier function of the repaired skin can be detected at the point of care of the measurement of trans-epidermal water loss (TEWL). This pilot study, we propose, many DFUs that are currently served with a CLOSED clinical decision may have had a history of biofilm infection and therefore remained functionally open. Considering that such incomplete wound closure may have a higher risk of wound recidivism, it becomes critically important that wound closure decisions be guided by functional tests in addition to factors currently considered. Importantly, substantial change in health impact may be achieved by a simple functional test as implemented by the measurement of trans epidermal water loss (TEWL). TEWL can be performed by clinical staff at the point of care within 15 minutes with minimum training using inexpensive hand- held pen like commercial gadgets approved for clinical use. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | 30 clinically diagnosed infected DFU patients will be recruited for this study in Phase A.Based on the expectation that 89% of these wounds will heal within 16 weeks of enrollment, 26 of these patients will continue with the study for Phase B. | ||||||||
| Condition |
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| Intervention | Other: no interventions
no interventions are planned
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Roy S, Elgharably H, Sinha M, Ganesh K, Chaney S, Mann E, Miller C, Khanna S, Bergdall VK, Powell HM, Cook CH, Gordillo GM, Wozniak DJ, Sen CK. Mixed-species biofilm compromises wound healing by disrupting epidermal barrier function. J Pathol. 2014 Aug;233(4):331-343. doi: 10.1002/path.4360. Epub 2014 May 27. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
30 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03479242 | ||||||||
| Other Study ID Numbers | 1808823394 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Chandan Sen, Indiana University | ||||||||
| Study Sponsor | Indiana University | ||||||||
| Collaborators | Stanford University | ||||||||
| Investigators |
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| PRS Account | Indiana University | ||||||||
| Verification Date | April 2020 | ||||||||