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Amelogenin, an extracellular matrix protein, in the treatment of venous leg ulcers and other hard-to-heal wounds: experimental and clinical evidence.

Romanelli M, Dini V, Vowden P, Agren MS - Clin Interv Aging (2008)

Bottom Line: Amelogenins are extracellular matrix proteins that, under physiological conditions, self-assemble into globular aggregates up to micron-sizes.Pre-clinical and clinical studies indicate that cutaneous wounds benefit from treatment with amelogenins.Case study evaluations indicate that the benefits of amelogenin therapy demonstrated in the RCT are being repeated in "real life" situations and that amelogenin therapy may also have a role to play in the treatment of other wound types such as diabetic foot ulcers.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology, University of Pisa, Pisa, Italy. m.romanelli@med.unipi.it

ABSTRACT
Amelogenins are extracellular matrix proteins that, under physiological conditions, self-assemble into globular aggregates up to micron-sizes. Studies with periodontal fibroblasts indicate that attachment to these structures increases the endogenous secretion of multiple growth factors and cell proliferation. Pre-clinical and clinical studies indicate that cutaneous wounds benefit from treatment with amelogenins. A randomized controlled trial (RCT) involving patients with hard-to-heal venous leg ulcers (VLUs) (ie, ulcers with a surface > or = area 10 cm2 and duration of > or = 6 months) showed that the application of amelogenin (Xelma, Molnlycke Health Care, Gothenburg, Sweden) as an adjunct treatment to compression results in significant reduction in ulcer size, improvement in the state of ulcers, reduced pain, and a larger proportion of ulcers with low levels of exudate, compared with treatment with compression alone. Amelogenin therapy was also shown to be safe to use in that there were no significant differences in adverse events noted between patients treated with amelogenin plus compression and those treated with compression alone. Case study evaluations indicate that the benefits of amelogenin therapy demonstrated in the RCT are being repeated in "real life" situations and that amelogenin therapy may also have a role to play in the treatment of other wound types such as diabetic foot ulcers.

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Related in: MedlinePlus

Median wound size reduction in the ITT population and sub-group ITTs following treatment with amelogenin and control. Copyright © 2006. Reproduced with permission from Vowden P, Romanelli M, Peter R, et al 2006. The effect of amelogenins (Xelma®) on hard-to-heal venous leg ulcers. Wound Rep Reg, 14:243–6.
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fig2: Median wound size reduction in the ITT population and sub-group ITTs following treatment with amelogenin and control. Copyright © 2006. Reproduced with permission from Vowden P, Romanelli M, Peter R, et al 2006. The effect of amelogenins (Xelma®) on hard-to-heal venous leg ulcers. Wound Rep Reg, 14:243–6.

Mentions: To satisfy the inclusion criteria for the study, patients had to have a VLU with a size between 5 and 25 cm2 and duration of at least six months that had been treated with controlled compression therapy for at least one month prior to enrolment. Patients were randomised to receive either amelogenin (Xelma®, Molnlycke Health Care, Gothenburg, Sweden) plus high compression (n = 62) or a control treatment consisting of a placebo gel (the amelogenin carrier vehicle) plus high compression (n = 61). The amelogenin was applied weekly under secondary dressings for up to a maximum of 12 weeks. Although no statistical differences could be identified between the groups as a whole, the percentage wound size reduction was greater in the group treated with amelogenin. A more detailed sub-group analysis was undertaken on patients with ulcers of greater than 10 cm2 at baseline and for ulcers of duration greater than 6 months. The results of this analysis demonstrated that there was a difference in percentage wound reduction in the group treated with amelogenin (33.8% vs 25.6%, respectively). It was highlighted that this difference was greatest for the group of patients (n = 61) with the larger ulcers (>10 cm2) (amelogenin 25% vs control 7.9%) (Figure 2).


Amelogenin, an extracellular matrix protein, in the treatment of venous leg ulcers and other hard-to-heal wounds: experimental and clinical evidence.

Romanelli M, Dini V, Vowden P, Agren MS - Clin Interv Aging (2008)

Median wound size reduction in the ITT population and sub-group ITTs following treatment with amelogenin and control. Copyright © 2006. Reproduced with permission from Vowden P, Romanelli M, Peter R, et al 2006. The effect of amelogenins (Xelma®) on hard-to-heal venous leg ulcers. Wound Rep Reg, 14:243–6.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2546471&req=5

fig2: Median wound size reduction in the ITT population and sub-group ITTs following treatment with amelogenin and control. Copyright © 2006. Reproduced with permission from Vowden P, Romanelli M, Peter R, et al 2006. The effect of amelogenins (Xelma®) on hard-to-heal venous leg ulcers. Wound Rep Reg, 14:243–6.
Mentions: To satisfy the inclusion criteria for the study, patients had to have a VLU with a size between 5 and 25 cm2 and duration of at least six months that had been treated with controlled compression therapy for at least one month prior to enrolment. Patients were randomised to receive either amelogenin (Xelma®, Molnlycke Health Care, Gothenburg, Sweden) plus high compression (n = 62) or a control treatment consisting of a placebo gel (the amelogenin carrier vehicle) plus high compression (n = 61). The amelogenin was applied weekly under secondary dressings for up to a maximum of 12 weeks. Although no statistical differences could be identified between the groups as a whole, the percentage wound size reduction was greater in the group treated with amelogenin. A more detailed sub-group analysis was undertaken on patients with ulcers of greater than 10 cm2 at baseline and for ulcers of duration greater than 6 months. The results of this analysis demonstrated that there was a difference in percentage wound reduction in the group treated with amelogenin (33.8% vs 25.6%, respectively). It was highlighted that this difference was greatest for the group of patients (n = 61) with the larger ulcers (>10 cm2) (amelogenin 25% vs control 7.9%) (Figure 2).

Bottom Line: Amelogenins are extracellular matrix proteins that, under physiological conditions, self-assemble into globular aggregates up to micron-sizes.Pre-clinical and clinical studies indicate that cutaneous wounds benefit from treatment with amelogenins.Case study evaluations indicate that the benefits of amelogenin therapy demonstrated in the RCT are being repeated in "real life" situations and that amelogenin therapy may also have a role to play in the treatment of other wound types such as diabetic foot ulcers.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology, University of Pisa, Pisa, Italy. m.romanelli@med.unipi.it

ABSTRACT
Amelogenins are extracellular matrix proteins that, under physiological conditions, self-assemble into globular aggregates up to micron-sizes. Studies with periodontal fibroblasts indicate that attachment to these structures increases the endogenous secretion of multiple growth factors and cell proliferation. Pre-clinical and clinical studies indicate that cutaneous wounds benefit from treatment with amelogenins. A randomized controlled trial (RCT) involving patients with hard-to-heal venous leg ulcers (VLUs) (ie, ulcers with a surface > or = area 10 cm2 and duration of > or = 6 months) showed that the application of amelogenin (Xelma, Molnlycke Health Care, Gothenburg, Sweden) as an adjunct treatment to compression results in significant reduction in ulcer size, improvement in the state of ulcers, reduced pain, and a larger proportion of ulcers with low levels of exudate, compared with treatment with compression alone. Amelogenin therapy was also shown to be safe to use in that there were no significant differences in adverse events noted between patients treated with amelogenin plus compression and those treated with compression alone. Case study evaluations indicate that the benefits of amelogenin therapy demonstrated in the RCT are being repeated in "real life" situations and that amelogenin therapy may also have a role to play in the treatment of other wound types such as diabetic foot ulcers.

Show MeSH
Related in: MedlinePlus