Juvista (Avotermin) in Scars Following Varicose Vein Removal

17:30 EDT 2nd July 2015 | BioPortfolio

Summary

This trial is being undertaken to investigate the efficacy and safety of Juvista in the improvement of scar appearance when administered to approximated wound margins following varicose vein surgery. The results from this trial will be used to select doses for investigation in future clinical trials with the compound.

Description

Patients undergoing bilateral removal of the saphenous vein (by ligation and stripping) will be invited to participate in the study. Consenting patients will undergo a detailed screening examination, after which suitability to progress to randomisation to the study will be confirmed.

Suitable screened patients will attend for scheduled surgery of vein removal as normal - this is termed "Day 0" At the time of wound closure, IMP will be administered via intra-dermal injection to each of the incisional groin wounds, and exit wounds.

Each patient will serve as their own control with one leg being administered active IMP (at either a 5, 50, 200 or 500ng/100 ul)of dose solution, whilst the other leg is administered placebo solution. The study is double-blinded, so neither the Investigator nor patient will know which leg wounds receive which treatment.

Further to Day 0, the patients are requested to attend for a further 5 follow up visits (Week 6, Month 3, Month 5, Month 7 & Month 12), where photographs of the scars will be taken, together with spectrophotometry readings to measure colour of the scar. At each visit, the Investigator and patient will rate their opinion of the scar, by global assessment scale & VAS, together with patient completed questionnaires.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Varicose Veins

Intervention

Avotermin

Location

Ziekenhuis Oost Limburg
Genk
Belgium
BT9 7AB

Status

Completed

Source

Renovo

Results (where available)

View Results

Links

Clinical Trials [78 Associated Clinical Trials listed on BioPortfolio]

A Randomised Study to Assess Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery

To investigate whether Betadine can reduce infection rates and recurrence rates following varicose veins surgery in a randomized double blind placebo controlled study.

Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence

The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the ...

Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista)

The purpose of this study is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volu...

FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins

Varicose vein disease is a common health problem, which causes much discomfort to patients. Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foa...

An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins

To determine the effect and safety of Varisolve® 0.125% [0.2%]

PubMed Articles [245 Associated PubMed Articles listed on BioPortfolio]

The Management of Varicose Veins.

This study aimed to review the current management modalities for varicose veins. There are a variety of management modalities for varicose veins. The outcomes of the treatment of varicose veins are di...

Recurrent varicose veins. Causes and neovascularisation. A 17-year experience.

The aim of the paper is to determine the causes of varicose vein recurrence and, when neovascularisation is suspected, to confirm or exclude its presence and to establish its contribution to the recur...

Lesion of pelvic organs in secondary varicose veins of the small pelvis.

The authors studied peculiarities of pelvic organs lesions in patients presenting with secondary small pelvic varicose veins (SPVV) induced by endured thrombosis of iliac veins. The study included a t...

Association between the Hypomethylation of Osteopontin and Integrin β3 Promoters and Vascular Smooth Muscle Cell Phenotype Switching in Great Saphenous Varicose Veins.

Lower extremity varicose veins are a common condition in vascular surgery and proliferation of vascular smooth muscle cells (VSMCs) in the intima is a significant pathological feature of varicosity. H...

A thematic analysis of experiences of varicose veins and minimally invasive surgery under local anaesthesia.

To gain insight into the experience of living with varicose veins and undergoing minimally invasive surgery under local anaesthesia in a private clinic.

Medical and Biotech [MESH] Definitions

Enlarged and tortuous VEINS.

Skin breakdown or ulceration caused by varicose veins in which there is too much hydrostatic pressure in the superficial venous system of the leg. Venous hypertension leads to increased pressure in the capillary bed, transudation of fluid and proteins into the interstitial space, altering blood flow and supply of nutrients to the skin and subcutaneous tissues, and eventual ulceration.

The sodium salts of the fatty acids in cod liver oil; an irritant and sclerosing agent used to treat varicose veins and arthritic joints.

An anionic surface-active agent used for its wetting properties in industry and used in medicine as an irritant and sclerosing agent for hemorrhoids and varicose veins.

Treatment of varicose veins, hemorrhoids, gastric and esophageal varices, and peptic ulcer hemorrhage by injection or infusion of chemical agents which cause localized thrombosis and eventual fibrosis and obliteration of the vessels.

More From BioPortfolio on "Juvista (Avotermin) in Scars Following Varicose Vein Removal"


Advertisement
 

Relevant Topic

Wound management
Latest News Clinical Trials Research Drugs Reports Corporate
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Advertisement