Clinical evaluation of the efficacy and safety of a medical device in various forms containing Triticum vulgare for the treatment of venous leg ulcers – a randomized pilot study

Abstract

This study was carried out to assess the efficacy and tolerability of the topical application of an aqueous extract of Triticum vulgare (TV) in different vehicles (cream, impregnated gauzes, foam, hydrogel, and dressing gel) for the treatment of venous lower leg ulcers. Fifty patients were randomized to receive one of the five investigational vehicles. Treatment was performed up to complete healing or to a maximum of 29 days. The wound size reduction from baseline was the primary efficacy variable, which was measured by means of a noninvasive laser scanner instrument for wound assessment. In all groups, apart from the foam group, a similar trend toward the reduction of the surface area was observed. The cream showed the greatest effect on the mean reduction of the lesion size. At last visit, six ulcers were healed: two in the cream group, three in the gauze group, and one in the dressing gel group. In the patients treated with the cream, the gauzes, the hydrogel, and the dressing gel, the reduction of lesion size was 40%–50%; the reduction was smaller in the foam group. No impact in terms of age on the healing process was found. The Total Symptoms Score decreased in all groups during the study; a greater efficacy in terms of signs/symptoms was observed in the patients treated with the gauzes. In the dressing gel group, one patient had an infection of the wound after 3 weeks of treatment and 2 of colonization, leading to a systemic antibiotic treatment. The events were judged as nonrelated to the device used. On the basis of the results, it could be argued that the medical device may be useful in the treatment of chronic venous ulcers.

Triticum vulgare extract exerts an anti-inflammatory action in two in vitro models of inflammation in microglial cells

“…A specific aqueous extract of Triticum vulgare (TVE-DAMOR) manufactured by Farmaceutici DAMOR (Naples, Italy) is currently an active component in the manufacture of certain pharmaceutical products already marketed in Italy and abroad under the brand name Fitostimoline ® , in the formulation of cream and medicated gauze and is commonly used for the treatment of decubitus ulcers, burns, scarring delays, dystrophic diseases, and in conditions in which it is necessary to stimulate re-epithelialization or tissue regeneration processes. In fact, it has been reported that the active component of Fitostimoline ® products (TVE) determines a marked acceleration of tissue repairing processes, stimulates chemotaxis and the fibroblastic maturation, and significantly increases the fibroblastic index, which are crucial points in the repairing processes [ 1 – 4 ].…”

Tratamientos innovadores utilizados en el manejo de las heridas crónicas

“…Como resultado final se observó reducción en el área de la superficie de la lesión, con mayor eficacia en las presentaciones de crema >50% (p <0.0095) e hidrogel >50% (p <0.0014), y en los signos y síntomas clínicos de la enfermedad con mayor eficacia en la presentación de gasas, por lo que se concluye que el dispositivo médico puede ser útil para el tratamiento de úlceras venosas crónicas, puesto que actúa como un apósito protector y tiene un mayor efecto de curación en heridas de la piel aguda tales como aquellas traumáticas y las quemaduras superficiales (24).…”

Molecular Mechanisms at the Basis of Pharmaceutical Grade Triticum vulgare Extract Efficacy in Prompting Keratinocytes Healing

“…In particular, scientific evidence has documented that wheat sprout oil has been used in traditional Iranian medicine for dermotonic and skin beauty, face freckles, and the moisturizing and repair of the minute pores of face skin [6]. TVE is commonly used for the treatment of decubitus ulcers, venous leg ulcers, sores, burns, scarring delays, dystrophic diseases, and, more broadly, in the presence of problems that are related to re-epithelialization or tissue regeneration [4,[7][8][9]. This extract is currently an active component in the brand name Fitostimoline ® (Farmaceutici Damor S.p.A., Naples, Italy).…”