NCT03479242

Diabetic Foot Ulcer Recurrence: Pilot Study

To Study Diabetic Foot Ulcer Recurrence With Trans Epidermal Water Loss Measured With Derma Lab

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetic Foot
• Ulcer Foot

Interventions

Type	Name	Description
OTHER	no interventions	no interventions are planned

Timeline

• Start date: 2019-01-25
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2018-03-27
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States