Autologous Serum-derived EV for Venous Trophic Lesions Not Responsive to Conventional Treatments

NCT04652531 | Unknown DMC

• 1 other identifier: CS2/1095/0090491
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Venous ulcers are defined by the presence of open lesions which represent the final stage of chronic venous disease or post-thrombotic syndrome. The risk factors for the development of venous ulcers include age, obesity, female sex, trauma, immobility, factor V mutation, thrombosis, venous agenesis. Recommendation by the current guidelines includes compression and advanced dressing. However, in several cases, they fail to change patients' outcome. The aim of this study is to identify an alternative therapy to treat venous trophic lesions not responding to traditional therapeutic approaches using extracellular vesicles obtained from autologous serum.

Conditions

Ulcer Venous

Keywords

Autologous EV; serum; ulcers; vascular disease

Outcome Measures

Primary Outcomes (1)

• Changes in the ulcer area from baseline to eight weeks

  Ulcer areas will be recorded at baseline and weekly using digital camera. A standard rule was positioned on the surface of the skin around the ulcers to standardize the images and to allow data analysis. The ImageJ analysis program will be used to calculate the ulcer area. A blinded investigator manually delimitated the ulcer area to calculate the area. The total area will be expressed in square centimeters.

  8 weeks

Secondary Outcomes (1)

• Pain change

  8 week

Study Arms (2)

Treatment

EXPERIMENTAL

In the treatment arm, the lesion will be treated with EV for 3 weeks once a week

Other: Autologous extracellular vesicles from serum

Internal control

SHAM COMPARATOR

The contralateral ulcer will be treated with a standard dressing and an elastic-compression bandage for 3 weeks.

Other: Autologous extracellular vesicles from serum

Interventions

Autologous extracellular vesicles from serum OTHER

Peri-wound injection of the vesicles will be performed in a sterile environment. Sterile gauze and an elastic-compression bandage will be applied.

Internal control; Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• :\> 85 years, diabetics, autoimmune diseases, neoplastic, arterial disease of the lower limbs.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU San Giovanni Battista

Turin, 10126, Italy

RECRUITING

Related Publications (3)

• Kholia S, Ranghino A, Garnieri P, Lopatina T, Deregibus MC, Rispoli P, Brizzi MF, Camussi G. Extracellular vesicles as new players in angiogenesis. Vascul Pharmacol. 2016 Nov;86:64-70. doi: 10.1016/j.vph.2016.03.005. Epub 2016 Mar 22.

  PMID: 27013016 RESULT

• Cavallari C, Ranghino A, Tapparo M, Cedrino M, Figliolini F, Grange C, Giannachi V, Garneri P, Deregibus MC, Collino F, Rispoli P, Camussi G, Brizzi MF. Serum-derived extracellular vesicles (EVs) impact on vascular remodeling and prevent muscle damage in acute hind limb ischemia. Sci Rep. 2017 Aug 15;7(1):8180. doi: 10.1038/s41598-017-08250-0.

  PMID: 28811546 RESULT

• Cavallari C, Figliolini F, Tapparo M, Cedrino M, Trevisan A, Positello L, Rispoli P, Solini A, Migliaretti G, Camussi G, Brizzi MF. miR-130a and Tgfbeta Content in Extracellular Vesicles Derived from the Serum of Subjects at High Cardiovascular Risk Predicts their In-Vivo Angiogenic Potential. Sci Rep. 2020 Jan 20;10(1):706. doi: 10.1038/s41598-019-55783-7.

  PMID: 31959759 RESULT

MeSH Terms

Conditions

Varicose Ulcer; Ulcer; Vascular Diseases

Condition Hierarchy (Ancestors)

Varicose Veins; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Felice Brizzi, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

• Giovanni Camussi, MD

  University of Turin, Italy

  STUDY CHAIR

Central Study Contacts

Maria Felice Brizzi, MD

CONTACT

+390116706653; mariafelice.brizzi@unito.it

Giovanni Camussi, MD

CONTACT

+390116709588; giovanni.camussi@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Peri-wound injection of the vesicles will be performed in a sterile environment. Sterile gauze and an elastic-compression bandage will be applied. The contralateral ulcer will be treated with a standard dressing and an elastic compression bandage. The patients will be evaluated on an outpatient basis on day 3 and then weekly.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 3, 2020
• Study Start: September 18, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)