Trials / Unknown
UnknownNCT02209662
Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers
A Multi-Center, Randomized Trial Comparing the Effectiveness of APIC-PRP to Control, When Added to Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 274 (estimated)
- Sponsor
- Cytonics Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be randomized into one of two groups, the Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce growth factors that can help in wound healing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | APIC-PRP | APIC-PRP |
| OTHER | Placebo, Saline plus standard of care | Placebo, Saline plus standard of care |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-10-01
- Completion
- 2015-12-01
- First posted
- 2014-08-06
- Last updated
- 2014-08-06
Source: ClinicalTrials.gov record NCT02209662. Inclusion in this directory is not an endorsement.