]>
IRCT20250302064900N1 IRCT 2025-05-29 Iranian academic center for education culture and research Evaluation of the Effect of an Injectable Hydrogel Carrier Containing Stem Cells on Diabetic Foot Ulcer Healing Evaluation of the Safety and Efficacy of Transplanting an Injectable Hydrogel Carrier Laden with Mesenchymal Stem Cells for the Treatment of Patients with Diabetic Foot Ulcers: Phase 1/2 Clinical Trial (Semi-industrial Production of an Injectable MSC-Loaded Hydrogel Carrier for Chronic Wound Therapy) 2025-06-22 anticipated 30 Complete https://irct.ir/trial/82342 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Block Randomization In this study, randomization will be conducted using a block randomization method with an allocation ratio of 1:1 (equal distribution between the two groups). A total of 30 participants will be randomly assigned equally into two groups: Group A: Receiving treatment with cell-loaded hydrogel Group B: Receiving routine treatment To maintain balance in the number of participants in each group throughout the study, blocks of four (Block size = 4) were used. There are six possible permutations of the two treatments (A and B) within a four-subject block: AABB – ABAB – ABBA – BBAA – BABA – BAAB The sequence of block assignments was randomly generated using the Random Allocation Software. In total, 7 full blocks (4 participants each) and 1 final block (2 participants, with a 1:1 ratio of A to B) were designed to allocate all 30 participants. The randomly selected treatment sequences for each block are as follows: Block Number Randomized Treatment Sequence 1 ABAB 2 BAAB 3 AABB 4 BBAA 5 ABBA 6 BABA 7 AABB 8 (Final) AB The final allocation of participants will be carried out upon enrollment, based on the predefined sequences. Allocation concealment will be ensured by a person not involved in the execution of the study. 1-2 Patients with diabetic ulcers. Intervention 1: Intervention group: Recipients of two million mesenchymal stem cells in a hydrogel carrier. Intervention 2: Control group: Recipients of standard treatment. Yes - There is a plan to make this available What will be shared: Part of the data - such as information related to the primary outcome or similar measures - can be shared. When: 12 months after publication To whom: the researchers of accademic centers Conditions: The applicant must submit a detailed proposal including the objectives, hypotheses, methodology, and the Statistical Analysis Plan (SAP). The proposal must be approved by the internal review committee (or ethics board) before any data are released. A commitment not to attempt to re-identify individual participants. The permissible scope of analyses (e.g., only descriptive analyses or pre-specified hypothesis tests). A prohibition on using the data for commercial purposes or product development without a separate agreement. An obligation to cite the data source in any publication or presentation. The applicant must submit the final analysis report and any resulting manuscripts or presentations to the core team within a specified timeframe (e.g., six months). Where to obtain: Mahboubeh Kazemi How to obtain: Administrative review Scientific and ethics review Negotiation and signing of the Data Use Agreement (DUA) Data preparation and transfer setup Comments:
public Halimeh Hassanzadeh
ACECR, Azadi Sq.,
Mashhad Iran (Islamic Republic of) 9177949367 +98 51 3199 7453 malihehhassanzadeh748@gmail.com Iranian academic center for education culture and research scientific Hadi Hosseinian
Azadi Sq.,
Mashhad Iran (Islamic Republic of) 9177948564 +98 915 521 4159 hoseinianh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Individuals with type 1 or type 2 diabetes who have had non-healing wounds for at least four weeks Diabetic ulcer grade 1–2 on the Wagner scale; ankle-brachial index (ABI) ≥ 0.7; HbA₁c < 12 %; wound size 2–20 cm² No use of medications that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic drugs 18 years 80 years Both Use of corticosteroids, immunosuppressive agents, and cytotoxic drugs Pregnancy and breast feeding Presence of renal failure (serum creatinine > 3 mg/dL); heart failure; uncontrolled systemic infection; neuropathic disorders other than diabetic neuropathy; peripheral vascular disease; and psychiatric illness or disability Age over 80 years E11.621 Type 2 diabetes mellitus with foot ulcer Treatment - Drugs Treatment - Drugs Intervention group: Recipients of two million mesenchymal stem cells in a hydrogel carrier. Control group: Recipients of standard treatment. Wound surface size. Timepoint: On days 3, 7, and 14, and then monthly for up to one year. Method of measurement: Measuring tool. Wound healing rate. Timepoint: On days 3, 7, and 14, and then monthly for up to one year. Method of measurement: macroscopic evaluation. Severity of wound pain. Timepoint: On days 3, 7, and 14, and then monthly for up to one year. Method of measurement: Pain score on a numeric rating scale. Survival Risk Percentage. Timepoint: day 365. Method of measurement: Plotting the survival curve. Risk of Amputation. Timepoint: 12 months after intervention. Method of measurement: Clinical Documentation. Wound-Related Quality of Life Index. Timepoint: 3 months after intervention. Method of measurement: Wound-QoL. Iranian academic center for education culture and research Approved 2025-02-22 Ethics Committee of Mashhad ACECR in Biomedical Research Azadi Square, Mashhad, Razavi Khorasan Province, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)