Identifying biomarkers for healing diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational platform study aims to test multiple biomarkers to determine which diabetic foot ulcers (DFUs) are more likely to heal. By collecting various biospecimens and clinical data from patients with active DFUs in outpatient settings, the study seeks to inform personalized management decisions and enhance future clinical trials for wound healing interventions. The flexible design allows for a wide range of studies relevant to DFUs, ensuring comprehensive data collection and analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Age 18 years or older.
3. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\]
4. Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU.
5. Agreement to adhere to protocol visits and provide all required biospecimens and clinical data.

Exclusion Criteria:

1. Participation in an interventional clinical trial for DFU within 1 month of Visit 1.
2. Currently receiving radiation to target area or chemotherapy.
3. Gangrene in any portion of the foot with the index ulcer.
4. Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.
5. Severe limb ischemia (SVS WIfl Ischemia grade 3).
6. Any concomitant medical or psychiatric condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study.

Where it's running

• University of Arizona College of Medicine
  Tucson, Arizona, United States Recruiting
• University of California - San Francisco
  San Francisco, California, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Northwell Health
  Lake Success, New York, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Wearable Insoles to Help Prevent Diabetic Foot Ulcers

  This study tests Orpyx sensory insoles added to standard care to see if they reduce diabetic foot ulcers in high-risk adults with neuropathy.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT05950659

• Single-layer placental graft plus standard care for stubborn diabetic foot ulcers

  This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.

  Recruiting Phase 4 Applied Biologics, LLC · Hollywood, Florida · NCT07159282

• Using human placental membrane wraps with regular wound care to help heal stubborn diabetic foot and venous leg ulcers

  This trial tests whether adding one of four human placental membrane wraps to standard wound care helps people with nonhealing diabetic foot or venous leg ulcers heal faster and more completely than standard care alone.

  Recruiting Phase 4 BioLab Holdings · Philidelphia, Pennsylvania · NCT07089602

• Evaluating new treatments for nonhealing diabetic foot and venous leg ulcers.

  This study is testing whether new treatments for stubborn diabetic foot and leg ulcers can help people heal better when combined with standard care compared to just standard care alone.

  Recruiting Phase 4 Tiger Biosciences, LLC. · Monroeville, Pennsylvania · NCT06826339

• Evaluating a new placental-based treatment for diabetic foot ulcers

  This study is testing if a new placental treatment can help adults with hard-to-heal diabetic foot ulcers get better faster when used alongside regular care.

  Recruiting Applied Biologics, LLC · Clinton Township, Michigan · NCT06564831

• Using dehydrated human amnion membrane to treat nonhealing diabetic foot ulcers

  This study is testing if adding dehydrated human amnion membrane to regular care can help people with stubborn diabetic foot ulcers heal better.

  Recruiting Axolotl Biologix · Thousand Oaks, California · NCT06550596

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.