Report on the clinical evaluation of glutaraldehyde cross-linked collagen (Keragen) implant treatment of heloma durum and heloma molle. Collagen Podiatric Investigation Group.
In this study, glutaraldehyde cross-linked collagen (Keragen implant) was injected subdermally beneath heloma durum and heloma molle for the relief of both the pain and keratoses associated with these lesions. Among 172 treated patients, 158 heloma durum and 44 heloma molle were treated with Keragen implant, whereas 121 heloma durum and 23 heloma molle served as uninjected controls that were treated only with palliative care. Most lesions (78% of heloma durum and 70% of heloma molle) required only one injection for correction and the mean treatment volumes were 0.46 ml. for heloma durum and 0.56 ml. for heloma molle. The incidence of pain, keratoses, and both pain and keratoses among Keragen implant-treated sites remained significantly lower than among control sites for up to 12 months after treatment. This is consistent with the data which demonstrated that the median time to recurrence of pain among implanted sites was 12.5 months, whereas it was only 2.0 months for control sites. Thus, these results indicate that subdermal injection of Keragen implant can provide significant reduction in the pain and keratoses associated with heloma durum and heloma molle.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000447:Aldehydes; D002145:Callosities / Q000150:complications / Q000473:pathology / Q000628:therapy*; D003432:Cross-Linking Reagents; D005260:Female; D005500:Follow-Up Studies; D005976:Glutaral; D006801:Humans; D007642:Keratosis / Q000209:etiology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D059408:Pain Management; D019736:Prostheses and Implants; D012008:Recurrence; D014034:Toes / Q000473:pathology
D000447:Aldehydes; D003432:Cross-Linking Reagents; D005976:Glutaral