Phase 2 Study of STIMULAN VG for Stage IV Pressure Ulcers with Osteomyelitis
This study is testing STIMULAN VG against standard care for people with severe (Stage IV) pressure ulcers that also have a bone infection (osteomyelitis). STIMULAN VG is a combination product inserted into the ulcer cavity before surgery, along with antibiotics. Standard care involves surgery to clean the ulcer and antibiotics. The study aims to see if STIMULAN VG is safe and how well it works compared to standard care. You might be able to join if you are 18 or older, have a Stage IV pressure ulcer needing surgery, and imaging shows a bone infection. The study will look at how successful the treatment is at 8 weeks. The current recruitment status is unclear.
- Study design
- This is an open-label, multi-center, randomized Phase 2 study. About 60 participants will be randomly assigned to receive either STIMULAN VG or standard care.
- What's involved
- Participants will undergo surgery to treat their pressure ulcer. Success will be measured at an 8-week follow-up visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed up at 8 weeks after treatment to assess individual patient success.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
At a glance
Conditions
Where it's being run
9 sites across 9 statesWho to contact
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What this trial measures
- Individual patient success and findings at the 8 week follow-up visit8 week
An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.