Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Placenta Stem Cells

    Drug

    Injection of 30 M placenta stem cells into/around the diabetic foot ulcer and along the anterior and posterior tibial arteries of the index leg.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Diabetic with Foot UlcerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Injection Sites Bleeding

Number of Injection Sites Bleeding

Time frame
Month 1
2

Number of Injection Sites Bleeding

Number of Injection Sites Bleeding

Time frame
Month 3
3

Number of Injection Sites Bleeding

Number of Injection Sites Bleeding

Time frame
Month 6
4

Number of Injection Sites Bleeding

Number of Injection Sites Bleeding

Time frame
Month 12

Secondary outcomes

1

Diabetic Foot Ulcer (DFU) size

DFU healing in this trial will be assessed by measuring the size of the DFU and plotting open wound size over the 12-month follow-up period.

Time frame
Month 12

Other outcomes

1

Change in Diabetic Peripheral Neuropathy - Semmes-Weinstein Monofilament and Vibration Test

The Semmes-Weinstein Monofilament Test is a diagnostic tool used to assess cutaneous touch and pressure sensation. By using calibrated nylon strands that buckle at specific forces, clinicians can evaluate peripheral nerve function and reliably detect the loss of protective sensation, primarily caused by conditions like diabetic neuropathy

Time frame
Months 1, 3, 6 and 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: