Double-blind randomized placebo-controlled trial of the use of granulocyte-macrophage colony-stimulating factor in chronic leg ulcers

Costa, Rafaela Lira Mendes; Jesus, Fernando Miguel; Aniceto, Cristina; Mendes, Mateus

doi:10.1016/s0002-9610(97)89589-x

Cited by 73 publications

(24 citation statements)

References 9 publications

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“…[40][41][42][43] Chronic wounds are associated with decreased TGF-b activity and our results suggest that restoration of TGFb in certain clinical settings may have therapeutic utility. 44 In this regard, the strategy of using RGD-based peptides (which activate av integrins) for treatment of chronic wounds is logical, and has shown some success both in vitro and in the clinic.…”

Section: Discussionmentioning

confidence: 64%

The integrin αv-TGFβ signaling axis is necessary for epidermal proliferation during cutaneous wound healing

et al. 2016

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Proliferation and migration of epidermal keratinocytes are essential for proper cutaneous wound closure after injury. av integrins and several of their ligands-vitronectin, TGFb and thrombospondin-are upregulated in healing wounds. However, the role of av integrins in wound re-epithelialization is unknown. Here, we show that genetic depletion or antibody-mediated blockade of pan-integrin av, or the specific heterodimer avb6, in keratinocytes limited epidermal proliferation at the wound edge and prevented reepithelialization of wounded human organotypic skin both in vivo and in vitro. While we did not observe a migration defect upon av blockade in vivo, av was necessary for keratinocyte migration over longer distances in organotypic skin. Integrin av is required for local activation of latent TGFb, and the wound healing defect in the setting of integrin av loss was rescued by exogenous, active TGFb, indicating that the av-TGFb signaling axis is a critical component of the normal epidermal wound healing program. As chronic wounds are associated with decreased TGFb signaling, restoration of TGFb activity may have therapeutic utility in some clinical settings.

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Section: Discussionmentioning

confidence: 64%

The integrin αv-TGFβ signaling axis is necessary for epidermal proliferation during cutaneous wound healing

et al. 2016

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“…16,25 The group treated by topical treatment alone did not show a clinical picture of important improvement. The effectiveness of medical-topical treatment is largely described, [24][25][26][27][28] but in this study, the use of FREMS may have decreased pain thus allowing the topical treatment to be administered more effectively. Furthermore, the improvement of the clinical picture was faster in the FREMS group in comparison with the group receiving topical treatment alone.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of the Frequency Rhythmic Electrical Modulation System for the Treatment of Chronic and Painful Venous Leg Ulcers in Older Adults

Santamato

Panza²,

Fortunato

et al. 2012

Rejuvenation Research

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Frequency rhythmic electrical modulation system (FREMS) is an innovative type of transcutaneous electrotherapy used in a rehabilitation setting for the treatment of pain, especially in diabetic patients. In a randomized clinical trial, we tested the hypothesis that FREMS is effective in the treatment of chronic and painful venous leg ulcers in 20 older patients. Group A (10 patients) received FREMS and topical treatment, whereas group B (10 patients) received topical treatment alone. Over a period of 3 consecutive weeks, 15 treatment sessions were done for each group. Wound healing and tissue repair were evaluated with the Visitrack digital planimetry system and photos. Pain was evaluated using the Visual Analogic Scale (VAS). The measurements were done at baseline and after 5, 10, and 15 days of treatment, with follow-up measurements after 15 and 30 days from the last treatment session. Group A showed a statistically significant decrease in ulcer area during the treatment and follow-up. The VAS score showed a statistically significant decrease after 5 and 10 days of treatment. Group B showed a statistically decrease in ulcer area after 5, 10, and 15 days of treatment with a reduction of VAS score only at 15 days of follow-up. At the end of the treatment, the comparison of the change in ulcer area and the change in VAS score of each group showed a statistically significant difference between groups, suggesting the therapeutic and analgesic efficacy of FREMS in reducing pain and area of chronic venous leg ulcers in older adults. Further investigation is needed to determine its reproducibility in larger case series or randomized clinical trials with longer follow-up periods.

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“…The first series reported the success of GM-CSF in 3 SCD patients with 5 ulcers, 1 of these cases received GM-CSF via subcutaneous and topical applications. All were cured, but the dripped dose of molgramostim was higher than our study and the treatment applied once daily [5]. The second series relied on subcutaneous injections at the ulcer margins, leading to the healing of 2/4 ulcers after 2 months [6].…”

Section: Discussionmentioning

confidence: 99%

Topical Effectiveness of Molgramostim (GM-CSF) in Sickle Cell Leg Ulcers

Méry

Girot²,

Aractingi³

2004

Dermatology

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Background: Leg ulcers are a frequently neglected, severe complication of sickle cell disease (SCD), responsible for significant altering quality of life. The management of leg ulcers remains disappointing. Local application of recombinant human granulocyte-macrophage colony-stimulating factor has been shown to be effective in several types of chronic wound healing. Methods: We report 5 homozygous sickle cell patients with 14 leg ulcers lasting from 1 month to 6 years, treated with topical dripping of molgramostim solution. Results: Healing was obtained for 9/14 ulcers, with no local or systemic adverse reactions. Comments: Molgramostim solution appears to be an adequate therapy for SCD leg ulcers but a more conclusive evaluation will depend on larger series of patients and other types of formulations for topical applications could be even more effective in the future.

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Double-blind randomized placebo-controlled trial of the use of granulocyte-macrophage colony-stimulating factor in chronic leg ulcers

Cited by 73 publications

References 9 publications

The integrin αv-TGFβ signaling axis is necessary for epidermal proliferation during cutaneous wound healing

The integrin αv-TGFβ signaling axis is necessary for epidermal proliferation during cutaneous wound healing

Effectiveness of the Frequency Rhythmic Electrical Modulation System for the Treatment of Chronic and Painful Venous Leg Ulcers in Older Adults

Topical Effectiveness of Molgramostim (GM-CSF) in Sickle Cell Leg Ulcers

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