Diabetic Foot Ulcer Recurrence: Pilot Study

Diabetic Foot Clinical Trial

— DFUCO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03479242
• Other study ID #: 1808823394
• Status: Terminated
• Start date: January 25, 2019
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Recurrence
• Ulcer
• Ulcer Foot

Intervention

Other:
• no interventions
no interventions are planned

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional skin closure in DFU in relation to biofilm infection	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	7 months

External Links

•   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