Diabetic Foot UlcerPhase 1NCT07686094
Placental Cells for Diabetic Foot Ulcers
A Phase 1 study testing Placenta Stem Cells in people with Diabetic Foot Ulcer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Placenta Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Mary-Clare Day, RN, 336-713-1343, maryclare.day@advocatehealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Placenta Stem Cells
- Keywords
- diabetic peripheral neuropathy, diabetic foot, placenta stem cells
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placenta Stem CellsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic with Foot Ulcer | Experimental | Type 2 diabetes mellitus with a non-healing (> 4 weeks) unilateral diabetic foot ulcer despite standard of care treatment Receives: Drug: Placenta Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Injection Sites Bleeding
Number of Injection Sites Bleeding
Measured: Month 1
Number of Injection Sites Bleeding
Number of Injection Sites Bleeding
Measured: Month 3
Number of Injection Sites Bleeding
Number of Injection Sites Bleeding
Measured: Month 6
Number of Injection Sites Bleeding
Number of Injection Sites Bleeding
Measured: Month 12
Number of Injection Sites infection/inflammation
Number of Injection Sites infection/inflammation
Measured: Month 1
Number of Injection Sites infection/inflammation
Number of Injection Sites infection/inflammation
Measured: Month 3
Number of Injection Sites infection/inflammation
Number of Injection Sites infection/inflammation
Measured: Month 6
Number of Injection Sites infection/inflammation
Number of Injection Sites infection/inflammation
Measured: Month 12
Number of Injection Sites with damage to surrounding tissue
Number of Injection Sites with damage to surrounding tissue
Measured: Month 1
Number of Injection Sites with damage to surrounding tissue
Number of Injection Sites with damage to surrounding tissue
Measured: Month 3
Number of Injection Sites with damage to surrounding tissue
Number of Injection Sites with damage to surrounding tissue
Measured: Month 6
Number of Injection Sites with damage to surrounding tissue
Number of Injection Sites with damage to surrounding tissue
Measured: Month 12
Number of Subjects with pain
Number of Subjects with pain
Measured: Month 1
Number of Subjects with pain
Number of Subjects with pain
Measured: Month 3
Number of Subjects with pain
Number of Subjects with pain
Measured: Month 6
Number of Subjects with pain
Number of Subjects with pain
Measured: Month 12
Number of Subjects with allergic reaction to placental cells
Number of Subjects with allergic reaction to placental cells
Measured: Month 1
Number of Subjects with allergic reaction to placental cells
Number of Subjects with allergic reaction to placental cells
Measured: Month 3
Number of Subjects with allergic reaction to placental cells
Number of Subjects with allergic reaction to placental cells
Measured: Month 6
Number of Subjects with allergic reaction to placental cells
Number of Subjects with allergic reaction to placental cells
Measured: Month 12
Number of Subjects with worsening of wound
Number of Subjects with worsening of wound
Measured: Month 1
Number of Subjects with worsening of wound
Number of Subjects with worsening of wound
Measured: Month 3
Number of Subjects with worsening of wound
Number of Subjects with worsening of wound
Measured: Month 6
Number of Subjects with worsening of wound
Number of Subjects with worsening of wound
Measured: 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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucian G. Vlad, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686094
- Sponsor's protocol ID
- IRB00152562
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No