Status:

COMPLETED

The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers

Lead Sponsor:

Attikon Hospital

Collaborating Sponsors:

Biomedical Research Foundation, Academy of Athens

Conditions:

Diabetic Foot

Eligibility:

All Genders

18-95 years

Phase:

PHASE4

Brief Summary

Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the treatment of diabetic foot ulcers, as it provides the necessary growth factors which enhance tissue healing. ...

Detailed Description

110 patients with diabetic foot ulcer will be randomized to receive UCB-PL gel or regular dressing with normal saline. The diabetic foot ulcers will be first debrided to remove any necrotic and infect...

Eligibility Criteria

Inclusion

  • age\>18 years old
  • patients with diabetic foot ulcer, foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces)
  • ulcer with area(length x width) measurement\<30 cm2
  • non-infected ulcers

Exclusion

  • pregnacy
  • venous ulcers
  • clinical signs and symptoms of infection
  • exposure of bone, muscle, ligaments, or tendons and the presence of tunneling

Key Trial Info

Start Date :

June 10 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2023

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT05404295

Start Date

June 10 2019

End Date

March 30 2023

Last Update

December 5 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Catherine Stavropoulos-Giokas

Athens, Attica, Greece, 11527

2

Vaia Lambadiari

Athens, Attica, Greece, 12462

The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers | DecenTrialz