Placental Cells for Diabetic Foot Ulcers
30 juni 2026 uppdaterad av: Wake Forest University Health Sciences
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
12
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mary-Clare Day, RN
- Telefonnummer: 336-713-1343
- E-post: maryclare.day@advocatehealth.org
Studieorter
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Atrium Health Wake Forest Baptist
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Kontakt:
- Mary-Clare Day, RN
- Telefonnummer: 336-713-1343
- E-post: maryclare.day@advocatehealth.org
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Diabetic with Foot Ulcer
Type 2 diabetes mellitus with a non-healing (> 4 weeks) unilateral diabetic foot ulcer despite standard of care treatment
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Injection Sites Bleeding
Tidsram: Month 1
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Number of Injection Sites Bleeding
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Month 1
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Number of Injection Sites Bleeding
Tidsram: Month 3
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Number of Injection Sites Bleeding
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Month 3
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Number of Injection Sites Bleeding
Tidsram: Month 6
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Number of Injection Sites Bleeding
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Month 6
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Number of Injection Sites Bleeding
Tidsram: Month 12
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Number of Injection Sites Bleeding
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Month 12
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Number of Injection Sites infection/inflammation
Tidsram: Month 1
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Number of Injection Sites infection/inflammation
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Month 1
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Number of Injection Sites infection/inflammation
Tidsram: Month 3
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Number of Injection Sites infection/inflammation
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Month 3
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Number of Injection Sites infection/inflammation
Tidsram: Month 6
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Number of Injection Sites infection/inflammation
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Month 6
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Number of Injection Sites infection/inflammation
Tidsram: Month 12
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Number of Injection Sites infection/inflammation
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Month 12
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Number of Injection Sites with damage to surrounding tissue
Tidsram: Month 1
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Number of Injection Sites with damage to surrounding tissue
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Month 1
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Number of Injection Sites with damage to surrounding tissue
Tidsram: Month 3
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Number of Injection Sites with damage to surrounding tissue
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Month 3
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Number of Injection Sites with damage to surrounding tissue
Tidsram: Month 6
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Number of Injection Sites with damage to surrounding tissue
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Month 6
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Number of Injection Sites with damage to surrounding tissue
Tidsram: Month 12
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Number of Injection Sites with damage to surrounding tissue
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Month 12
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Number of Subjects with pain
Tidsram: Month 1
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Number of Subjects with pain
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Month 1
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Number of Subjects with pain
Tidsram: Month 3
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Number of Subjects with pain
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Month 3
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Number of Subjects with pain
Tidsram: Month 6
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Number of Subjects with pain
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Month 6
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Number of Subjects with pain
Tidsram: Month 12
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Number of Subjects with pain
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Month 12
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Number of Subjects with allergic reaction to placental cells
Tidsram: Month 1
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Number of Subjects with allergic reaction to placental cells
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Month 1
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Number of Subjects with allergic reaction to placental cells
Tidsram: Month 3
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Number of Subjects with allergic reaction to placental cells
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Month 3
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Number of Subjects with allergic reaction to placental cells
Tidsram: Month 6
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Number of Subjects with allergic reaction to placental cells
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Month 6
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Number of Subjects with allergic reaction to placental cells
Tidsram: Month 12
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Number of Subjects with allergic reaction to placental cells
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Month 12
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Number of Subjects with worsening of wound
Tidsram: Month 1
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Number of Subjects with worsening of wound
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Month 1
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Number of Subjects with worsening of wound
Tidsram: Month 3
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Number of Subjects with worsening of wound
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Month 3
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Number of Subjects with worsening of wound
Tidsram: Month 6
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Number of Subjects with worsening of wound
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Month 6
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Number of Subjects with worsening of wound
Tidsram: Month 12
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Number of Subjects with worsening of wound
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Month 12
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Diabetic Foot Ulcer (DFU) size
Tidsram: Month 12
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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.
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Month 12
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Diabetic Peripheral Neuropathy - Semmes-Weinstein Monofilament and Vibration Test
Tidsram: Months 1, 3, 6 and 12
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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
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Months 1, 3, 6 and 12
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Lucian G. Vlad, MD, Atrium Health Wake Forest Baptist
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 december 2028
Avslutad studie (Beräknad)
1 december 2028
Studieregistreringsdatum
Först inskickad
30 juni 2026
Först inskickad som uppfyllde QC-kriterierna
30 juni 2026
Första postat (Faktisk)
7 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00152562
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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