Clinical trial NCT04591691: C-myc Biomarker Study for Diabetic Foot Ulcers
Official title: Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers - C-myc and Phosphorylated Glucocorticoid Receptor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetic Foot
Diabetic Foot Ulcer
Diabetic Wound
Keywords: biomarker
C-myc
phosphorylated glucocorticoid receptor
DFC
Diabetic Foot Consortium
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Stanford University
name: University of Miami
name: University of Pittsburgh
name: University of California, San Francisco
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-10-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Type 1 or Type 2 Diabetic patients with a diabetic foot ulcer

Brief summary: This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years or older.
4. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
5. Foot ulcer of diabetic etiology, with all of the following characteristics:

   1. Ulcer size \> 0.5 cm2 and \< 12 cm2 at least 2 cm from any other ulcer, and
   2. Ulcer with Wagner grade 1 or 2 In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
6. Patients with neuropathic or neuro-ischemic ulcers with adequate circulation to allow healing to the affected extremity as demonstrated by at least 2 of the following within 6 months of Visit 1:

   1. Ankle brachial index (ABI) ≥ 0.6 with Doppler Waveforms, or
   2. Absolute ankle pressure ≥ 70 mm Hg, or
   3. Toe pressure ≥ 40 mmHg, or
   4. TcPO2 ≥ 40 mmHg
7. Willingness to comply with standard of care which includes an initial surgical debridement of the wound.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patient participating in an interventional clinical trial within 1 month of Visit 1
2. Currently receiving radiation to target area or chemotherapy
3. Participants with Charcot's foot or other foot deformities that prevents adequate targeted ulcer offloading
4. Participant with active severe infection or osteomyelitis at the time of screening
5. History of cancer within last 3 years, other than non-melanoma skin cancer
6. Known or suspected malignancy of current study ulcer
7. Use of adjunctive therapy within previous 30 days
8. Currently receiving medication considered to be systemic glucocorticoids
9. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral vascular intervention
10. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study

Primary outcomes:
measure: Proportion of participants with complete wound healing by week 12, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Miami
name: Marjana Tomic-Canic
role: PRINCIPAL_INVESTIGATOR
References: