The Safety of Skin Substitute Application for Chronic Diabetic Foot Ulcer

Phase 1

Recruiting

• 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; E10.621; E11.621

• Registration Number: IRCT20080728001031N33
• Lead Sponsor: ATI tech pharmed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

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

Pregnancy
Malignancy not in remission for 5 y
Severe malnutrition (serum albumin <2.0)
Alcohol or drug abuse
Random BS = 450 mg/dL
Urine ketones
Use of corticosteroids, immunosuppressive or cytotoxic agents, Coumadin
History of bleeding disorder
Positive viral markers (HIV, HBV, HCV, HTLV, CMV)
Participation in another study in previous 30 d
Conditions compromise ability to complete the study
Clinical evidence of infection at the beginning of the treatment phase
Evidence of osteomyelitis
Evidence of gangrene
Charcot deformity
Nondiabetic etiology
Tunnels or sinus tracts
Ulcer >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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
lcer 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.