Printed from Voxsanity (voxsanity.com.au) — NCT07581145 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Type 2 Diabetes
Phase 3 Type 2 Diabetes Trial, Recruiting
NCT07581145
Who may 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 might be able to join this trial:
- You have been diagnosed with type 2 diabetes for at least 6 months
- You are between 18 and 90 years old
- You have a foot ulcer (open wound) located below the ankle bone — if you have more than one, the largest will be used for the study
- After wound cleaning, your ulcer is a certain minimum and maximum size (roughly between a small pea and a palm-sized wound — confirm exact sizing with trial site)
Who may not be able to join:
- You are currently using, or have used in the last 3 months, a type of diabetes medication called a GLP-1 agonist (such as semaglutide or liraglutide)
- You are currently using a type of diabetes medication called a DPP-IV inhibitor (such as sitagliptin or saxagliptin)
- You have previously had acute pancreatitis (a serious inflammation of the pancreas)
- Your foot ulcer currently shows signs of infection
- The blood flow to your foot is very poor (low toe blood pressure — confirm with trial site)
- You are currently receiving chemotherapy drugs or steroid medicines taken throughout the whole body (not just a cream or local treatment)
- You have been hospitalised for a serious heart or blood vessel event, procedure, or leg surgery in the last 3 months, or have one planned
- You cannot take or tolerate the study medication for any reason
- You have another serious health condition that the doctors believe makes it unsafe for you to participate
- You have issues with alcohol or drug misuse, or anything else that might make it hard for you to follow the study plan
- You have taken part in another clinical drug trial or a foot ulcer healing trial in the last 3 months
- You are currently pregnant, breastfeeding, or planning to become pregnant
- You are a woman who could potentially become pregnant and do not have a confirmed recent menstrual period or have a positive pregnancy test (confirm with trial site)
- You are a woman who could potentially become pregnant and are not using a highly effective form of contraception (such as the pill, an IUD, implant, or other reliable method)
- You are a man with a female partner who could become pregnant, and neither of you are using adequate contraception together (confirm with trial site)
- You are not able to come in for weekly visits due to planned activities or travel
- You are not able to speak or understand Danish or another language used at the trial site, or you are otherwise unable to communicate well enough to participate
- You are not able to give written, signed consent to join the study
- You are taking any medication that the doctors believe could interfere with wound healing
- You have a significant illness or health condition (unrelated to your diabetes) that could affect the study results
- You have active cancer, or have had cancer in the last 3 years (a past history of a common type of skin cancer called basal cell carcinoma is allowed)
- Your life expectancy is less than 12 months
- Your wound is caused mainly by poor blood supply that has not been treated, or you are a candidate for a procedure to improve blood flow to help healing
- Your wound is not related to diabetes
- You have a bone infection (osteomyelitis) in the leg with the wound being treated
- You have signs of a spreading skin/tissue infection (cellulitis) around the wound, such as redness, tenderness, fever, or chills
- You have had Achilles tendon lengthening surgery on the same leg as your wound within the last 3 months
- Your wound has dead tissue, pus, or tunnels that cannot be fully removed by wound cleaning
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Ole L Svendsen, MD, University Hospital Bispebjerg and Frederiksberg
Phone: +45 21830863
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Ole Lander Svendsen
Registry
ClinicalTrials.gov
Start date
24 April 2026
Est. completion
1 December 2028
Where this trial is recruiting
🇩🇰 Denmark
Primary endpoints
Proportion of clinical healed index foot ulcer at week 20
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.