Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called Arginine Butyrate (given through a drip into a vein) compared with standard local wound dressings, for people with leg or skin ulcers. A total of 23 participants started the first phase of the trial — 11 in the standard dressing group and 12 in the Arginine Butyrate group. The trial then had a crossover phase, where some participants from the standard dressing group could switch to the Arginine Butyrate treatment. The main thing the trial was measuring was whether an ulcer shrank by at least 25% of its original size, which was counted as "healed" for the purposes of this study. The reported data shows that, for the primary measure (ulcer shrinking by at least 25%), 24% of ulcers in the standard local care dressing group met this threshold, compared with 78% in the Arginine Butyrate group. For the secondary measure — the percentage of ulcers that closed completely within three months — the reported figures were 8% in the standard dressing group and 31% in the Arginine Butyrate group. These are the numbers as submitted to the registry; no further breakdown by individual patient characteristics was reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 20955402) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Sickle Cell Disease Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You have been diagnosed with a significant sickle cell condition, including Hemoglobin SS, Hemoglobin S-beta thalassemia, or a related hemoglobin variant
- You are between 16 and 60 years old
- You have one or more ulcers on your lower leg or ankle that have not healed for at least 6 months
- Your liver is functioning normally, with liver enzyme levels at or below 250 IU
- Your kidneys are functioning normally, with creatinine levels at or below 1.2 mg/mL (for adults) or 0.9 mg/mL (for teenagers)
- If you have a skin infection (cellulitis) or other infection around the ulcer, you must have received antibiotic treatment for it before joining the trial
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You are pregnant
- You are able to have children but are not using effective birth control
- You have liver problems or abnormal liver enzyme levels above 250 IU
- You have kidney problems or creatinine levels above 1.2 mg/mL (adults) or 0.9 mg/mL (teenagers)
- You are currently receiving regular blood transfusions as an ongoing treatment
- You have had or are currently receiving chemotherapy for cancer
- You are currently taking a type of medication called butyrate derivatives (confirm with trial site)
- You are currently taking steroid medications (corticosteroids)
- You have seizures that are not well controlled by treatment
- You have another condition that may weaken your immune system
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area
Other options
Data last synced from ClinicalTrials.gov: 17 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.