治験レーダーAI | ||
|---|---|---|
治験 NCT07498218（対象：糖尿病足潰瘍（DFU）、Granulation of Chronic Diabetic Wounds）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue 第I相・フェーズ1 24
A Prospective, Multi-center, Randomized, Double-blind, Controlled, Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
- Ayu / P01-2019 / CT/ VG
VELGRAFT
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Investigational Product Subject receives applications of VELGRAFT | an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix VELGRAFT is applied topically. Cells used in VELGRAFT are derived from bone marrow from an FDA-registered establishment. The MSCs in VELGRAFT have been tested for the human leukocyte antigen-2 (HLA-2) marker to minimize rejection due to an immune response by the patient and has undergone a battery of biocompatibility testing. Additionally, cells contained in VELGRAFT are cultured in xenogeneic-free medium, reducing r...もっと見る |
実薬対照薬Control Group Subject receives Standard of Care treatment | Standard of Care of Diabetic Foot Ulcers Standard of Care includes Moist Wound Dressing |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Safety of VELGRAFT to Treat DFUs | To assess the safety of VELGRAFT to treat DFUs as compared to standard of care therapy through the difference between the VELGRAFT IP and the control groups for all treated patients in the proportion of patients reporting adverse events during the active study period. The investigator will assess the relationship between study therapy and the occurence of each AE/SAE and will use clinical judgment to determine if there is a reasonable possibility that the IP was responsible for the AE/SAE being reported. Determination of relatedness to the IP will be defined according to one of the following categories:
* Definite - The AE/SAE is clearly related to the IP
* Probable - The AE/SAE is likely related to the IP
* Possible - The AE/SAE may be related to the IP
* Unlikely - The AE/SAE is doubtfully related to the IP
* Unrelated - The AE/SAE is clearly NOT related to the IP AE/SAE's will be assessed by CTCAE Version 5.0 and safety data of the study will be evaluated by an independent DSMB. | From Enrollment to End of Follow-Up at 169 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Efficacy of VELGRAFT | To assess the efficacy of VELGRAFT for healing DFUs compared to standard of care therapy. This will be assessed by the difference between the two treatment arms in the proportion of participants with complete wound closure at week 12 and 14. Complete wound closure is defined as complete skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits, Week 12 and 14. Wounds will be measured by Imito Wound Measurement Software. | From Enrollment to weeks 14 |
Wound Closure Rate | To Evaluate wound closure rate over the course of the trial. This will be measured by the proportion of participants with complete wound closure by 24 weeks. | From Enrollment to 24 weeks |
Ulcer Recurrence Rate | To measure ulcer recurrence rate over the course of the trial | Enrollment through study completion at an average of 169 days. |
Assess Re-epithelialization | to Assess Re-epithelialization over the course of the Trial | From Enrollment through study completion, an average of 169 days |
Assess scar by scar scales | To Assess scar by scar scales via the Patient and Observer Scar Assessment Scale. The Patient and Observer Scar Assessment scale is a 5-point scale. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 5 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation). | Enrollment through study completion, an average of 169 days |
Assess Quality of Life | To Assess patient reported outcomes for quality of life via patient reported outcomes. Patient reported outcomes include the Wound Pain Visual Analogue Scale and the pruritus Visual Analogue Scale which share a common unit of measurement. The Wound Pain Visual Analogue Scale is a 10-cm (100-mm) straight line, anchored by "no pain" (0) and "worst imaginable pain" (10 or 100 mm), used to objectively measure subjective pain intensity. Patients mark the line to indicate pain levels, with higher scores indicating higher severity and a need for intervention. The Pruritus Visual Analog Scale (VAS) is a validated, subjective 10-cm (100-mm) linear tool used to measure itch intensity, ranging from "no pruritus" (0) to "worst imaginable itch" (10 cm). Patients or owners mark the line to indicate severity, which is then measured to quantify intensity, often categorized as Mild, Moderate, or Severe. | From Enrollment through study completion, an average of 169 days. |
Assess Quality of Life | To Assess patient reported outcomes for quality of life via patient reported outcomes. Patient reported outcomes include the SF-36 questionnaire, a widely used, self-reported, 36-question survey that measures physical and mental health-related quality of life over the past four weeks. Covering eight health domains, it evaluates functioning, well-being, and limitations, providing scores that, when higher, indicate better health. | From screening through study completion, an average of 169 days. |
Age ≥ 18 years
Patient has current diagnosis of type 1 or type 2 diabetes mellitus
Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
i. Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30mmHg, OR ii. ABIs (Ankle brachial index) with results of ≥0.7 and ≤1.2, OR iii. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
For female patients of childbearing potential, commitment to using a medically accepted means of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout study period and tests negative on a pregnancy test
Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment
Able and willing to wear an off-loading device or orthopedic shoe
Gangrene is present on any part of the affected foot
Ulcer is of non-diabetic pathophysiology
Patient's ulcer is over a Charcot deformity
Ulcer total surface area > 20 cm2
Osteomyelitis, cellulitis, or other evidence of infection
Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids
Patient has AIDS, HIV, or cardiac (ejection fraction less than 50% on 2D-ECHO; t-wave inversion on ECG), endocrine (hypothyroidism), disease, or present symptoms/complaints suggestive of gastrointestinal, neurological, or immune disease, that in the opinion of the Investigator, would make the patient an inappropriate candidate for this wound healing study.
Patient with any of the below physiological parameters:
i. BP systolic >140 or <90 mmHg or diastolic >90 or <60mmHg ii. Pulse <60 or >100bpm iii. Respiratory Rate <9 and >20 bpm iv. Pulse Oximetry <94% in room air v. Temp >100.4 degrees Fahrenheit vi. ALT and AST >2 times the upper limit of normal (ULN) vii. Abnormal bilirubin unless subject has Gilbert's viii. eGFR <60 mL/min/1.73 m2 by CKD-EPI ix. Platelet Count <100,000 x. HbA1c: ≥8.5% xi. Hemoglobin: ≤10g/dL
Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D).
Patients with Wagner Grades 2-6 ulcers.
Patient has had a previous lower extremity amputation.
Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening
Female patients who are nursing, pregnant, or planning on becoming pregnant during the study period.
Patient is unwilling or unable to comply with the postoperative visits necessary for data collection.
Patients with known hypersensitivity to the components of the product or shipping medium.
Ayu, Inc.MCRA