Diabetic Foot - Treatment
Essaven Gel -
updated: 15 March 2008
Four-week treatment with Essaven gel in diabetic microangiopathy--a placebo-controlled, randomized study
Angiology. 2001 Dec;52 Suppl 3:S49-55
De Sanctis MT, Cesarone MR, Incandela L, Belcaro G, Ricci A, Griffin M.
The involvement of the microcirculation in diabetic microangiopathy (DM) may be the cause of severe incapacitation and ulceration. DM is characterized by a diffuse increase in skin flux, reduction in venoarteriolar response, and increased permeability, resulting in edema. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 15 subjects with DM and neuropathy and treated with local application of EG for 4 weeks. Measurements of composite, average laser Doppler (LDF) flux (ten measurements points), in standardized conditions showed a significant decrease in flux in the EG group. The flux decrease was present even after 1 week after the suspension of treatment. Changes in the control group were not significant. In the placebo group, variations were limited (associated with skin manipulation and gel application). In conclusion local treatment for 4 weeks with standardized application of EG improves the microcirculation in subjects with DM. The changes are detectable even 1 week after the end of the treatment period.
Publication Types:
- placebo-controlled, randomized study
Online - Abstract
Microvascular alterations in diabetic microangiopathy: topical treatment with Essaven gel--a placebo-controlled, randomized study
Angiology. 2001 Dec;52 Suppl 3:S35-41
Incandela L, Belcaro G, Cesarone MR, De Sanctis MT, Griffin M.
The involvement of the microcirculation in diabetic microangiopathy (DM) may be cause of severe invalidity and ulceration. Diabetic microangiopathy (DM) is characterized by a diffuse increase in skin flux, reduction in venoarteriolar response, and increased capillary permeability resulting in edema; skin PO2 is decreased and CO2 increased. In this condition, capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local foot care and treatment with Essaven gel (EG) in 30 subjects with DM and neuropathy and localized, small (<0.5 cm in maximum diameter) ulcers treated with a single acute application of EG. Measurements of laser Doppler (LDF) flux, PO2 and PCO2 in standardized conditions showed positive microcirculatory changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the active EG group lasting for at least 6 hours after application. Changes in the control group were not significant. In the placebo group variations were limited, mainly associated with skin manipulation and gel application. In conclusion, local treatment with one single standardized application of Essaven gel, in comparison with placebo, acutely improves the microcirculation in subjects with DM and small ulceration even with a single acute application. The microcirculatory changes are detectable even 10 hours after application.
Publication Types:
- placebo-controlled, randomized study
Online - Abstract
Two-week topical treatment with Essaven gel in patients with diabetic microangiopathy--a placebo-controlled, randomized study
Angiology. 2001 Dec;52 Suppl 3:S43-8.
Cesarone MR, Incandela L, Belcaro G, De Sanctis MT, Ricci A, Griffin M.
The involvement of the microcirculation in diabetic microangiopathy (DM) causes of severe incapacitation and ulceration. DM is characterized by a diffuse increase in flux, reduction in venoarteriolar response, associated with increased permeability resulting in edema and altered function of microlymphatics. In DM, skin PO2 is decreased and CO2 increased. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 35 subjects with DM and neuropathy and localized, small (< 0.5 cm in maximum diameter) ulcers treated for 2 weeks. Measurements of laser Doppler (LDF) flux, PO2, and PCO2 in standardized conditions showed positive microcirculatory changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the active EG group. Changes in the control group were not significant. In the placebo group variations were limited (mainly associated with skin manipulation and gel application). In conclusion, local treatment for 2 weeks with standardized application of EG acutely improves the microcirculation in subjects with DM and small ulceration.
Publication Types:
- placebo-controlled, randomized study
Online - Abstract
Topical treatment of venous microangiopathy in patients with venous ulceration with Essaven gel--a placebo-controlled, randomized study
Angiology. 2001 Dec;52 Suppl 3:S29-34
De Sanctis MT, Incandela L, Belcaro G, Cesarone MR.
The involvement of the microcirculation in chronic venous insufficiency (CVI), due to venous hypertension, causes venous hypertensive microangiopathy (VHM) and ulceration. VHM is characterized by enlarged, convoluted capillaries; microvascular thrombosis; obliteration of some capillaries; increase in flux, permeability, and edema and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations eventually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate local treatment with Essaven gel (EG) in subjects with venous microangiopathy and ulcers. Measurements of laser Doppler flux, PO2, and PCO2 in standardized conditions showed positive changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo-EG was applied). In conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single acute application
Publication Types:
- a placebo-controlled, randomized study
Online - Abstract
Publication Types:
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