Cell therapy in diabetic foot ulcer

Phase 1

Recruiting

• Conditions: diabetic foot ulcer.; Diabetes mellitus due to underlying condition with foot ulcer; E08.621

• Registration Number: IRCT20080901001159N26
• Lead Sponsor: ???? ??????? ???? ? ???? ??? ?????? ??????? ???? ????? ?????

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age 18 -60
Type 1 or Type 2 diabetes
Able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations
Ulcer size 2-20 cm2
Ulcer duration of more than 4 weeks, unresponsive to standard wound care
No clinical signs of infection
Serum creatinine <3 mg/dl
HbA1c <12%
ABI between 0·7 and 1·2

Exclusion Criteria

wound duration of >52 weeks without intermittent healing
Index ulcer probing to tendon, muscle, capsule or bone
Currently receiving radiation or chemotherapy
Known or suspected malignancy of current ulcer
Diagnosis of autoimmune connective tissue disease
Use of biomedical/topical growth factor within previous 30 days
Pregnant or breast feeding
Taking medications considered to be immune system modulators
Allergy or known sensitivity to Gentamicin, Streptomycin or bovine collagen
Wounds improving more than 20% over the 4-week run-in period of the trial using standard of care.
Patient taking Cox-2 inhibitors.
HBV, HCV or HIV positive.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound extent (cm2). Timepoint: Before intervention, every week up to 1 month, and every month up to 6 months. Method of measurement: Image J software.

Secondary Outcome Measures

Name	Time	Method
Safety. Timepoint: intervention start date up to 6 months. Method of measurement: Medical history and physical examination.