Placental Cells for Diabetic Foot Ulcers
30. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
12
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Mary-Clare Day, RN
- Telefonnummer: 336-713-1343
- E-Mail: maryclare.day@advocatehealth.org
Studienorte
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North Carolina
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Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Atrium Health Wake Forest Baptist
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Kontakt:
- Mary-Clare Day, RN
- Telefonnummer: 336-713-1343
- E-Mail: maryclare.day@advocatehealth.org
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Injection Sites Bleeding
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Month 12
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Number of Subjects with worsening of wound
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Month 12
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Diabetic Foot Ulcer (DFU) size
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Diabetic Peripheral Neuropathy - Semmes-Weinstein Monofilament and Vibration Test
Zeitfenster: Months 1, 3, 6 and 12
|
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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Lucian G. Vlad, MD, Atrium Health Wake Forest Baptist
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Oktober 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2028
Studienabschluss (Geschätzt)
1. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
30. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. Juni 2026
Zuerst gepostet (Tatsächlich)
7. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB00152562
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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