Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic with Foot Ulcer | Experimental | Type 2 diabetes mellitus with a non-healing (> 4 weeks) unilateral diabetic foot ulcer despite standard of care treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary-Clare Day, RN | Contact | 336-713-1343 | maryclare.day@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Lucian G. Vlad, MD | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Months 1, 3, 6 and 12 |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |