Placental Cells for Diabetic Foot Ulcers
ConditionDiabetic Foot Ulcer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers.
Eligibility criteria
Qualifiers
Diagnosed with Type 2 Diabetes mellitus (DM) - for at least 1 year
Unilateral non-healing Diabetic Foot Ulcer (DFU) > 2 cm2 and ≤ 4 cm2 (length × width) for at least four weeks despite Atrium Health Wake Forest Baptist standard of care treatment (which can include total contact cast, knee high air cast, and/or compression wrap)
No new diabetes medication for at least 2 weeks pre-treatment
Subjects must be willing to avoid steroids for the week prior to procedure day
Disqualifiers
Clinical signs of active infection requiring systemic antibiotic therapy less than 7 days prior to enrollment.
Radiographic or clinical evidence of active and untreated osteomyelitis at the target ulcer site. Current use of systemic immunosuppressive therapy, including chronic corticosteroids (equivalent to >10 mg/day prednisone for >14 days).
Hemoglobin (Hgb) A1C >12.0 at screening or time in range for the blood glucose level (TIR) less than 30%. Hb A1c should not be used for patient with hypoalbuminemia or anemia in the past 3 months and for patients with Chronic Kidney disease stage 4. For patients who have Continuous Glucose Monitor (CGM), instead of Hb A1c, TIR (time in range) less than 30 % will be used.
Patients who are unable / unwilling to tolerate an effective offloading approach. This includes total contact cast, soft felted cast or knee high fracture boot.
Trial design
Treatments tested in this trial
- Placenta Stem Cells
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov