Diabetic Foot Ulcer Recurrence: Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | January 25, 2019 |
| End Date: | December 31, 2021 |
| Contact: | Jennifer Mohnacky |
| Email: | jmohnack@iu.edu |
| Phone: | 317-278-2715 |
To Study Diabetic Foot Ulcer Recurrence With Trans Epidermal Water Loss Measured With Derma Lab
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.
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.
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.
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.
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
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