NCT00463125UnknownPhase 2
Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial
Università Politecnica delle Marche2 sites in 1 country40 target enrollmentStarted: March 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Time from diagnosis to complete ulcer healing
Study Overview
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 i.v. 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Digital ulcers (NPUAP stage≥2) in patients with SSc (ACR criteria)
- •Current medical treatment with intravenous prostanoids
- •Availability to come to our centre for weekly ulcer assessment and medication
- •Capacity to give informed consent
Exclusion Criteria
- •Clinical evidence of skin infection
- •Current treatment with Bosentan or Sildenafil
- •Presence of necrotic material occluding the wound bed.
Outcomes
Primary Outcomes
Time from diagnosis to complete ulcer healing
Rate of ulcers healed during the follow up period (10 weeks)
Secondary Outcomes
- Rate of ulcers healed during the follow up period (10 weeks)
- Pain evaluation (VAS scale)
- Rate of complications
Investigators
Study Sites (2)
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