Diabetic Foot Ulcer Recurrence: Pilot Study (DFUCO)

• ClinicalTrials.gov Identifier: NCT03479242
• Recruitment Status: Active, not recruiting
• First Posted: March 27, 2018
• Last Update Posted: December 14, 2021
• Sponsor: Indiana University
• Collaborator: Stanford University
• Information provided by (Responsible Party): Chandan Sen, Indiana University

Study Description

Brief Summary:

In this prospective pilot study, patients with DFU visiting the Indiana 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.

Condition or disease	Intervention/treatment
Diabetic Foot; Ulcer Foot	Other: no interventions

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 Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: To Study Diabetic Foot Ulcer Recurrence With Trans Epidermal Water Loss Measured With Derma Lab
• Actual Study Start Date: January 25, 2019
• Estimated Primary Completion Date: February 15, 2022
• Estimated Study Completion Date: February 15, 2022

Groups and Cohorts

Intervention Details:

• Other: no interventions
  no interventions are planned

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Indiana

IU Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Stanford University

Investigators

• Principal Investigator: Chandan K Sen, PhD; Professor

More Information

Additional Information:

1. Ahmed AS, Antonsen EL. Immune and vascular dysfunction in diabetic wound healing. J Wound Care. 2016;25 Suppl 7:S35-46 

2. Aye M, Masson EA. Dermatological care of the diabetic foot. Am J Clin Dermatol. 2002;3:463-474 

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.

• Responsible Party: Chandan Sen, Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT03479242
• Other Study ID Numbers: 1808823394
• First Posted: March 27, 2018
• Last Update Posted: December 14, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Recurrence; Pathologic Processes; Disease Attributes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases