Placental Cells for Diabetic Foot Ulcers

NCT07686094 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB00152562
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcer

Keywords

diabetic peripheral neuropathy; diabetic foot; placenta stem cells

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (1)

• Diabetic Foot Ulcer (DFU) size

  Month 12

Other Outcomes (1)

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

  Months 1, 3, 6 and 12

Study Arms (1)

Diabetic with Foot Ulcer

EXPERIMENTAL

Type 2 diabetes mellitus with a non-healing (\> 4 weeks) unilateral diabetic foot ulcer despite standard of care treatment

Drug: Placenta Stem Cells

Interventions

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.

Diabetic with Foot Ulcer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Lucian G. Vlad, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary-Clare Day, RN

CONTACT

336-713-1343; maryclare.day@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)