CLINICAL EFFICACY OF PLATELET GEL FROM CORD BLOOD FOR THE TREATMENT OF DIABETIC FOOT ULCERS

CLINICAL EFFICACY OF PLATELET GEL FROM CORD BLOOD FOR THE TREATMENT OF DIABETIC FOOT ULCERS - CLINICAL EFFICACY OF CBPG FOR THE TREATMENT OF DIABETIC FOOT ULCERS

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000510-22-ES

Enrollment

220

Registered

2015-05-08

Start date

2015-07-28

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot ulcers MedDRA version: 18.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004858

Interventions

Product Name: Gel de plaquetas de sangre de cordón umbilical Product Code: Gel de plaquetas de sangre de cordón umbilical Pharmaceutical Form: Gel INN or Proposed INN: Gel de plaquetas de sangre de co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients >18 year with diabetic ulcer 2. Ulcer dimensions (5cm2 2.5g/dl 6. Informed consent 7. Patient able to understand the conditions of the study and to participate for its entire duration Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Patient with serious medical conditions that contraindicate the patient's participation in the study (tumors, severe chronic renal failure, autoimmune diseases, severe ischemic heart disease) 2. Patient with uncontrolled diabetes mellitus (HbA1c >9) or severe metabolic diseases 3. Heel ulcer and outcomes of amputation 4. Patient with present clinical infection 5. Bone exposure 6. Patient taking or having taken chronically drugs that can affect the metabolism, and in general regeneration and tissue repair (bisphosphonates, chemotherapy, chronic therapy with corticosteroids) 7. Use of experimental drugs 8. Patients not able to follow the procedures of the Protocol and to sign the informed consent. 9. Current pregnancy 10. Negative Pressure (possible use in control arm patients)

Design outcomes

Primary

Measure	Time frame
Main Objective: To increase ulcer?s healing from 40% in controls to >60% in treated patients;Secondary Objective: Percent skin ulcer closure area. Number and type of adverse events that will occur in diabetic patients during treatment period. Cost of treatment.;Primary end point(s): Percent reduction (100% = healing) of ulcer's size;Timepoint(s) of evaluation of this end point: Week 4 of treatment	—

Measure

Time frame

Main Objective: To increase ulcer?s healing from 40% in controls to >60% in treated patients;Secondary Objective: Percent skin ulcer closure area. Number and type of adverse events that will occur in diabetic patients during treatment period. Cost of treatment.;Primary end point(s): Percent reduction (100% = healing) of ulcer's size;Timepoint(s) of evaluation of this end point: Week 4 of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Ulcer's infection, osteomyelitis, amputation, AE monitored with CTCAE v 3.0;Timepoint(s) of evaluation of this end point: Week 4 of treatment	—

Countries

Spain

Contacts

Public ContactDepartamento de I+D+i

Banc de Sang i Teixits

etahull@bst.cat34935573500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026