The Safety of Skin Substitute Application for Chronic Diabetic Foot Ulcer

The Safety & Feasibility of Bi-Layered Allogeneic Cultured Keratinocyte and Fibroblast Skin Substitute Application for Chronic Diabetic Foot Ulcers: Clinical Trial Phase I

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20080728001031N33

Enrollment

Registered

2022-07-03

Start date

2022-07-23

Completion date

Unknown

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Type 1 diabetes mellitus with foot ulcer. Condition 2: Type 2 diabetes mellitus with foot ulcer. Type 1 diabetes mellitus with foot ulcer Type 2 diabetes mellitus with foot ulcer

Interventions

Intervention group: Name of substance used: Bi-layered skin substitute. Chemical composition and its concentration: Allogenic cultured keratinocyte and fibroblast cells. The number of 2 million fibrob

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 18-80 years Both gender Type I or II diabetes ABI = 0.8 HgA1c = 8% Palpable pulse Ulcer university of Texas score=2A Ulcer = 4w presented ulcer >2w under standard care Ulcer on plantar surface of foot Ulcer Size = 2.0 cm2 Ulcer depth = 1cm

Exclusion criteria

Exclusion criteria: Pregnancy Malignancy not in remission for 5 y Severe malnutrition (serum albumin 20 cm2 (longest dimension > 5 cm) Elective osseous procedures to the study foot within 30 d before Increased or decreased in size by = 20% in screening period Severe hepatic impairment (LFT = 2 * ULN) or renal impairment (Cr> 2.5 mg/dl)

Design outcomes

Primary

Measure	Time frame
Short-term or long term, systemic or local, severe or mild, and related or unrelated to cell therapy adverse effects. Timepoint: Before the intervention, at the time of intervention, 3, 7, 14, 18, 21, 28 days and 6, 8, 12, 16, 20 and 24 weeks after the intervention. Method of measurement: Physician assessment by physical examination.	—

Secondary

Measure	Time frame
Ulcer healing rate. Timepoint: 12th week after intervention. Method of measurement: ImageJ software.;50% improvement in wound size. Timepoint: 12th week after intervention. Method of measurement: ImageJ software.;Mean rate of wound healing during the first 12 weeks. Timepoint: Days 3, 7, 14, 18, 21 and 28 as well as weeks 6, 8 and 12 after the intervention. Method of measurement: Physician evaluation and solar calendar.;The rate of recurrence of the wound at the site of the previous healing. Timepoint: 24th week after the intervention. Method of measurement: Physician evaluation and examination.	—

Measure

Time frame

Ulcer healing rate. Timepoint: 12th week after intervention. Method of measurement: ImageJ software.;50% improvement in wound size. Timepoint: 12th week after intervention. Method of measurement: ImageJ software.;Mean rate of wound healing during the first 12 weeks. Timepoint: Days 3, 7, 14, 18, 21 and 28 as well as weeks 6, 8 and 12 after the intervention. Method of measurement: Physician evaluation and solar calendar.;The rate of recurrence of the wound at the site of the previous healing. Timepoint: 24th week after the intervention. Method of measurement: Physician evaluation and examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShayan Farzanbakhsh

Royan Institute

Shayan.farzanb@yahoo.com+98 21 2251 8388

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026