Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetic Foot Ulcer Recurrence: Pilot Study (DFUCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479242
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Chandan Sen, Indiana University

Tracking Information
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
 (submitted: January 2, 2019)
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
Original Primary Outcome Measures
 (submitted: March 20, 2018)
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • Diabetic Foot
  • Ulcer Foot
Intervention Other: no interventions
no interventions are planned
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2018)
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:

  1. Age ≥ 18
  2. Willing to comply with protocol instructions, including all study visits and study activities.
  3. Diabetic foot ulcers
  4. Adequate arterial blood flow as evidenced by at least one of the following:

    1. TCOM > 30 mmHg
    2. Ankle-brachial index ≥0.7
    3. Toe pressure > 30 mmHg

Exclusion Criteria:

  1. Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent)
  2. Wounds closed or to be closed by flap or graft coverage
  3. Prisoners
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jennifer Mohnacky 317-278-2715 jmohnack@iu.edu
Contact: Sashwati Roy, PhD 3172782706 roysa@iu.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Chandan Sen, Indiana University
Study Sponsor Indiana University
Collaborators Stanford University
Investigators
Principal Investigator: Chandan K Sen, PhD Professor
PRS Account Indiana University
Verification Date April 2020