NCT04558775

Brief Summary

This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

September 16, 2020

Last Update Submit

July 19, 2023

Conditions

DiabetesDiabetic FootDiabetic Foot UlcerDiabetic WoundDiabetic

Keywords

biomarkerTEWLtrans epidermal water lossDFCDiabetic Foot Consortium

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing

    1 up to 16 weeks after wound closure

Secondary Outcomes (3)

  • Time to DFU wound recurrence after complete wound healing

    Up to 16 weeks after wound closure

  • Participant self-report of DFU wound recurrence

    16 weeks

  • Clinician assessment of DFU wound recurrence

    16 weeks

Study Arms (1)

Observational Cohort

Other: Observational

Interventions

ObservationalOTHER

no intervention

Observational Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult diabetic patients with diabetic foot ulcer

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria at Visit 1:
  • Age \> 18 years.
  • Willing and able to comply with protocol instructions.
  • Clinically diagnosed DFU is closed.
  • Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
  • Provides written informed consent.
  • Confirmation that the target DFU that was assessed as healed at Visit 1 remains healed two weeks later (at Visit 2).

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • DFU wounds closed more than 2 weeks before Visit 1, or to be closed by flap or graft coverage
  • Closed DFU site whose size or location would not allow five separate TEWL measurements
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Miami

Miami, Florida, 33126, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 25261, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Chandan K Sen, PhD

    Indiana University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor of Biostatistics, SABER Director

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

June 17, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

US(6)