Placental Cells for Diabetic Foot Ulcers
2026年6月30日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
12
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mary-Clare Day, RN
- 電話番号：336-713-1343
- メール：maryclare.day@advocatehealth.org
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Atrium Health Wake Forest Baptist
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コンタクト：
- Mary-Clare Day, RN
- 電話番号：336-713-1343
- メール：maryclare.day@advocatehealth.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Injection Sites Bleeding
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Month 12
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Number of Subjects with worsening of wound
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Month 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diabetic Foot Ulcer (DFU) size
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Diabetic Peripheral Neuropathy - Semmes-Weinstein Monofilament and Vibration Test
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Lucian G. Vlad, MD、Atrium Health Wake Forest Baptist
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年6月30日
最初の投稿 (実際)
2026年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月7日
QC基準を満たした最後の更新が送信されました
2026年6月30日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。