Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463125
Status:
UNKNOWN
Last Update Posted:
2007-04-20
First Post:
2007-04-19
Brief Title:
Platelet Gel in Systemic Sclerosis
Sponsor:
Università Politecnica delle Marche
Organization:
Università Politecnica delle Marche
Study Overview
Official Title:
Platelet Gel for Digital Ulcers in Patients With SSc a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic sclerosis scleroderma SSc is a connective tissue disease characterized by a progressive fibrosis of the skin and visceral organs
A diffuse cutaneous microvascular damage occurs in 30-50 of patients often leading to digital ulcers development responsible for pain functional disability disfiguring scars digital bony reabsorption infection and osteomyelitis
Although the availability of drugs as iv prostacyclin analogs oral vasodilating agents oral phosphodiesterase-5 inhibitors oral endothelin receptor blockers has improved the prognosis digital ulcers are frequently refractory to the medical treatment
Preliminary data seems to demonstrate a pivotal role played by some growth factors PDGF TGF beta 1-2 IGF in the process of ulcers healing tissue regeneration and re-epithelization Alpha-granules in the platelets store these factors in significant amount
Recently the application of a gel rich in platelets prepared from donors plasma taken by apheresis seems to be beneficial to enhance pressure and vascular ulcers healing
On the basis of these considerations we expect that application of a platelet gel combined with advanced dressing and conventional medical therapy makes a more rapid healing of digital ulcers in patients with systemic sclerosis We decided to conduct a double blind RCT to test this hypothesis
A diffuse cutaneous microvascular damage occurs in 30-50 of patients often leading to digital ulcers development responsible for pain functional disability disfiguring scars digital bony reabsorption infection and osteomyelitis
Although the availability of drugs as iv prostacyclin analogs oral vasodilating agents oral phosphodiesterase-5 inhibitors oral endothelin receptor blockers has improved the prognosis digital ulcers are frequently refractory to the medical treatment
Preliminary data seems to demonstrate a pivotal role played by some growth factors PDGF TGF beta 1-2 IGF in the process of ulcers healing tissue regeneration and re-epithelization Alpha-granules in the platelets store these factors in significant amount
Recently the application of a gel rich in platelets prepared from donors plasma taken by apheresis seems to be beneficial to enhance pressure and vascular ulcers healing
On the basis of these considerations we expect that application of a platelet gel combined with advanced dressing and conventional medical therapy makes a more rapid healing of digital ulcers in patients with systemic sclerosis We decided to conduct a double blind RCT to test this hypothesis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None