Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02389010
• Date of registration: 10/03/2015
• Prospective Registration: No
• Primary sponsor: Centro Nazionale Sangue
• Public title: Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers CBPG-DFU
• Scientific title: Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers
• Date of first enrolment: January 2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02389010
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Italy, Spain

Contacts

• Name: Maurizio Marconi, MD
• Affiliation: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano

• Name: Simonetta Pupella, MD
• Affiliation: Centro Nazionale Sangue

Key inclusion & exclusion criteria

Inclusion Criteria

1. Age = 18 years

2. Patient with diabetic foot ulcers

3. Size of ulcer (5 cm^2 < X < 30 cm^2)

4. Absence of undermining or tunneling

5. TUC I and II C. At the time of 1st application, ulcer is not clinically infected
(smelly, perilesional edematous tissue, hot and flushed)

6. Effective Revascularization ( TcPO2 foot >30 mmHg and Patency of one or more tibial
arteries until the ankle/foot)

7. Informed consent

8. Patient able to understand the conditions of the study and to participate for its
entire duration

Exclusion criteria

1. Patient with serious medical conditions that contraindicate the patient's
participation in the study

2. Ineffective revascularization

3. Heel ulcer and outcomes of amputation

4. Patient with present clinical infection

5. Bone and/or sinew exposure

6. Current pregnancy

7. Use of experimental drugs.

8. Negative Pressure (possible use in control arm patients)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Foot Ulcers

Intervention(s)

Biological: Allogeneic cord blood platelet gel-CBPG

Other: Standard Local Medications-SLM

Primary Outcome(s)

Number of closed skin ulcers within 4 weeks of treatment with cord blood platelet gel (CBPG) vs standard local medications [Time Frame: 4 weeks]

Secondary Outcome(s)

Percent skin ulcer closure area [Time Frame: 4 weeks]

Cost of treatment [Time Frame: 4 weeks]

Number and type of adverse events [Time Frame: 4 weeks]

Secondary ID(s)

1-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Italian National Cord Blood Network (ITCBN)