Diabetic Foot Ulcer Recurrence: Pilot Study

NCT03479242 | Terminated

• 1 other identifier: 1808823394
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Ulcer Foot

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

no interventions OTHER

no interventions are planned

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18
• Willing to comply with protocol instructions, including all study visits and study activities.
• Diabetic foot ulcers
• Adequate arterial blood flow as evidenced by at least one of the following:
• TCOM \> 30 mmHg
• Ankle-brachial index ≥0.7
• Toe pressure \> 30 mmHg

You may not qualify if:

• Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent)
• Wounds closed or to be closed by flap or graft coverage
• Prisoners

Sponsors & Collaborators

• Indiana University: lead
• Stanford University: collaborator

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related 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.

  PMID: 24771509 BACKGROUND

Related 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

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Study Officials

• Chandan K Sen, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: March 27, 2018
• Study Start: January 25, 2019
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)