Placental Cells for Diabetic Foot Ulcers

Phase 1 Safety Trial of Placental Stem Cells (PLSC) to Accelerate the Healing of Diabetic Foot Ulcers

The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: Placenta Stem Cells

Detailed Description

This is a prospective, non-randomized, single institution, Phase 1 safety trial to evaluate the safety of placental stem cells and the rate of diabetic foot ulcer healing in a population of subjects with non-healing diabetic foot ulcers for at least 4 weeks. The trial will also explore the clinical outcomes of placental stem cells treatment on diabetic peripheral neuropathy. Furthermore, the trial will evaluate the effect of the placental stem cells on serum biomarkers associated with diabetic foot ulcers and diabetic peripheral neuropathy (measured pre- and post-treatment) and correlate the biomarker levels with any changes in diabetic foot ulcers and diabetic peripheral neuropathy. Twelve adult subjects with non-healing diabetic foot ulcers for at least four weeks from diagnosis and not more than 12 months with wound sizes ≥ 2 cm2 and ≤ 4 cm2 will be recruited and treated. Subjects will be followed for 12 months after treatment.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mary-Clare Day, RN; Phone Number: 336-713-1343; Email: maryclare.day@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
      • Contact: Mary-Clare Day, RN; Phone Number: 336-713-1343; Email: maryclare.day@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• Current alcohol or substance abuse that, in the opinion of the investigators, would interfere with study participation.
• Active malignancy or malignancy related limb amputation.
• Women that are pregnant or planning to become pregnant during the study.
• Patients with albumin levels less than 3.5 or prealbumin levels less than 18.
• Subjects with any conditions that the clinical Investigator believes may jeopardize the safety of the patient to participate in the trial.
• Severe peripheral arterial disease (PAD) (Ankle-Brachial Index (ABI) less than 0.5) or TCOM (Transcutaneous Oximetry Measurement) less than 40 mmHg.
• TWSB > 30 cm2 (total wound surface burden)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetic with Foot Ulcer; Type 2 diabetes mellitus with a non-healing (> 4 weeks) unilateral diabetic foot ulcer despite standard of care treatment	Drug: Placenta Stem Cells; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Injection Sites Bleeding	Number of Injection Sites Bleeding	Month 1
Number of Injection Sites Bleeding	Number of Injection Sites Bleeding	Month 3
Number of Injection Sites Bleeding	Number of Injection Sites Bleeding	Month 6
Number of Injection Sites Bleeding	Number of Injection Sites Bleeding	Month 12
Number of Injection Sites infection/inflammation	Number of Injection Sites infection/inflammation	Month 1
Number of Injection Sites infection/inflammation	Number of Injection Sites infection/inflammation	Month 3
Number of Injection Sites infection/inflammation	Number of Injection Sites infection/inflammation	Month 6
Number of Injection Sites infection/inflammation	Number of Injection Sites infection/inflammation	Month 12
Number of Injection Sites with damage to surrounding tissue	Number of Injection Sites with damage to surrounding tissue	Month 1
Number of Injection Sites with damage to surrounding tissue	Number of Injection Sites with damage to surrounding tissue	Month 3
Number of Injection Sites with damage to surrounding tissue	Number of Injection Sites with damage to surrounding tissue	Month 6
Number of Injection Sites with damage to surrounding tissue	Number of Injection Sites with damage to surrounding tissue	Month 12
Number of Subjects with pain	Number of Subjects with pain	Month 1
Number of Subjects with pain	Number of Subjects with pain	Month 3
Number of Subjects with pain	Number of Subjects with pain	Month 6
Number of Subjects with pain	Number of Subjects with pain	Month 12
Number of Subjects with allergic reaction to placental cells	Number of Subjects with allergic reaction to placental cells	Month 1
Number of Subjects with allergic reaction to placental cells	Number of Subjects with allergic reaction to placental cells	Month 3
Number of Subjects with allergic reaction to placental cells	Number of Subjects with allergic reaction to placental cells	Month 6
Number of Subjects with allergic reaction to placental cells	Number of Subjects with allergic reaction to placental cells	Month 12
Number of Subjects with worsening of wound	Number of Subjects with worsening of wound	Month 1
Number of Subjects with worsening of wound	Number of Subjects with worsening of wound	Month 3
Number of Subjects with worsening of wound	Number of Subjects with worsening of wound	Month 6
Number of Subjects with worsening of wound	Number of Subjects with worsening of wound	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Months 1, 3, 6 and 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Lucian G. Vlad, MD, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: diabetic foot; diabetic peripheral neuropathy; placenta stem cells
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot
• Other Study ID Numbers: IRB00152562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No