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Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers (CBPG-DFU)

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ClinicalTrials.gov Identifier: NCT02389010
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Italian National Cord Blood Network (ITCBN)
Information provided by (Responsible Party):
Centro Nazionale Sangue

Brief Summary:
A novel method (PCT n. WO 2010/007502 A2, 2010) has been developed to obtain platelet gel from umbilical cord blood (CBPG). The main advantages so far identified in CBPG as compared to platelet gel derived from adult platelets relate to the lack of microbiological contamination in the former and to a different profile of growth factors concentrations, such as a higher content of VEGF and lower content of TGF in CBPG. Recent developments have led to a procedure in which CBPG can be prepared, stored in a cryopreservation bag and applied to the skin ulcer without breaking the sterility chain. In spite of promising results on allogeneic CBPG, a randomized clinical trial of sufficient statistical power to detect significant advantages (clinical and economical) will be performed in patients affected by diabetic foot ulcers and randomly treated with CBPG versus standard local medications (SLM).This study is a multicenter (8 centers) controlled randomized clinical trial. Outcomes: (1) primary objective is to evaluate the number of closed skin ulcers within 4 weeks of treatment with CBPG vs standard local medications; (2) secondary objectives are percent skin ulcer closure area, number and type of adverse events and cost of treatment. Sample size calculation: 95 + 5 (dropout) test and 95 + 5 (dropout) control patients ensure 80% power to detect as statistically significant (p<0.05) >60% healing in test vs 40% healing in control.Each clinical centre has been invited to enrol 15 treated and 15 control patients, according to local availability in 12 months. CB units are routinely collected after mother's informed consent before and after placenta delivery in accredited public cord blood banks belonging to the Italian Cord Blood Network (ITCBN) coordinated by the Centro Nazionale Sangue (CNS). After storage and transportation at monitored room temperature, the units will be processed for the preparation of CBPG within 48 hours of collection. CBPG will be prepared according to standard procedures with a defined final platelet concentration (0.8-1.2 x 109/L). The CBPC units will be finally cryopreserved in a -80°C freezer in view of the clinical use of the CBPG, which will require thawing at 37°C in a waterbath and activation with Calcium gluconate. For SLM, each clinical center will use their validated standard procedures.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Biological: Allogeneic cord blood platelet gel-CBPG Other: Standard Local Medications-SLM Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers
Study Start Date : January 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Allogeneic Cord Blood Platelet Gel-CBPG
For the medication of patients, one CBPG unit (mean volume 10 mL, range 5-15; mean platelet concentration 1 x 109/L, range 0.8 - 1.2 x 109/L. 10 mL in plasma) will be administered every 3-4 days. CBPG units, cryopreserved and stored in a plastic bag in a -80°C freezer, will be thawed at 37°C in a waterbath and activated with Calcium gluconate and immediately transported to sites of clinical use and applied to the skin ulcer without breaking the sterility chain.
Biological: Allogeneic cord blood platelet gel-CBPG
For the medication of patients, one CBPG unit (mean volume 10 mL, range 5-15; mean platelet concentration 1 x 109/L, range 0.8 - 1.2 x 109/L. 10 mL in plasma) will be administered every 3-4 days. CBPG units, cryopreserved and stored in a plastic bag in a -80°C freezer, will be thawed at 37°C in a waterbath and activated with Calcium gluconate and immediately transported to sites of clinical use and applied to the skin ulcer without breaking the sterility chain.

Active Comparator: Standard Local Medications-SLM
1 administration every 3-4 days for 4 weeks. Each clinical center will use their validated standard local medications. Details and specifications of the local standard medication procedures will be collected from each participating centre.
Other: Standard Local Medications-SLM
Each clinical center will use their validated standard local medications. Details and specifications of the local standard medication procedures will be collected from each participating centre.




Primary Outcome Measures :
  1. Number of closed skin ulcers within 4 weeks of treatment with cord blood platelet gel (CBPG) vs standard local medications [ Time Frame: 4 weeks ]
    The major end-point will be to test feasibility and compare efficacy of treating diabetic foot skin ulcers (Texas C I-II) with allogeneic CBPG versus SLM and their respective costs. The primary outcome measures will be: number of healed wounds after 4 weeks of CBPG treatment versus control and time to achieve complete closure. Lesions will be assessed two times per week. Wounds with less than 50% closure after 4 weeks will be considered as a failure. The main target will be to validate the clinical use of an allogeneic product matching several requirements: to comply with routine process of periodic blood collection and blood component preparation; to maintain closed and aseptic conditions through the entire process; to contain platelet growth factor concentrations reported to be clinically effective; to be suitable to treat one medium-size ulcer per aliquot, defined as 'CBPG unit' (on average 10 mL of CB plasma containing 10 billion platelets); to be ABO compatible with the patient.


Secondary Outcome Measures :
  1. Percent skin ulcer closure area [ Time Frame: 4 weeks ]
  2. Number and type of adverse events [ Time Frame: 4 weeks ]
  3. Cost of treatment [ Time Frame: 4 weeks ]
    Cost analysis will include costs associated with blood component preparation, storage and activation; the administration of CBPG or standard local medications; dressing materials; and personnel workload (technicians and nurses).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389010


Locations
Italy
Ospedaliero-Universitaria di Bologna
Bologna, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Italy
Presidio Ospedaliero "Spirito Santo"
Pescara, Italy
Azienda Ospedalero-Universitaria Pisana
Pisa, Italy
Presidio Ospedaliero "E. Morelli"
Reggio Calabria, Italy
Policlinico Umberto I - "Sapienza" Università di Roma
Roma, Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Torino, Italy
Spain
Hospital de la Santa Creu i Sant Pau - Servicio de Angiología, Cirugía Vascular y Endovascular
Barcelona, Catalonia, Spain, 08026
Sponsors and Collaborators
Centro Nazionale Sangue
Italian National Cord Blood Network (ITCBN)
Investigators
Principal Investigator: Maurizio Marconi, MD Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano
Study Chair: Simonetta Pupella, MD Centro Nazionale Sangue

Additional Information:
Publications of Results:

Responsible Party: Centro Nazionale Sangue
ClinicalTrials.gov Identifier: NCT02389010     History of Changes
Other Study ID Numbers: 1-2014
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centro Nazionale Sangue:
Umbilical Cord Blood
Diabetic Foot
Ulcer
Cost
Effectiveness
Safety
Platelet Gel
Cord Blood Platelet Gel
Adverse Event

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Endocrine System Diseases
Foot Diseases
Ulcer
Pathologic Processes
Diabetic Angiopathies
Leg Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies