Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older, of any gender.
• Women who are not pregnant, not breastfeeding, and not planning to become pregnant during the study — and who are either past menopause, have had a sterilisation procedure (such as removal of the ovaries, fallopian tubes, or uterus, or tubal ligation at least 6 months before the study starts), or are using an accepted form of contraception throughout the study (such as hormonal contraceptives, an intrauterine device, a vasectomised partner, total abstinence in line with their usual lifestyle, or a double-barrier method).
• Women of childbearing potential must have a negative pregnancy test before joining.
• People who have a venous leg ulcer or diabetic foot ulcer that has not been healing for more than 4 weeks.
• People whose wound has shown less than 50% reduction in size over the last 4 weeks, with no visible signs of healing.
• People whose wound measures between 2 cm² and 24 cm² in size.
• If a person has more than one wound that may be eligible, the largest wound would be selected for the study.
• People who are able and willing to follow the study requirements and attend scheduled visits.
• People who have given written informed consent to participate.

Who may not be able to join:

• People who are unable or unwilling to follow the study schedule and requirements.
• People who are currently pregnant.
• Women of childbearing potential who are not using appropriate contraception.
• People who are currently breastfeeding.
• People whose wound has been treated with engineered tissue or scaffold materials within the 30 days before the first treatment visit.
• People whose wound has already shown clear signs of improvement — defined as a 50% or greater reduction in wound size — in the four weeks before enrolment.
• People with other medical conditions that, in the opinion of the study doctor, could put their safety at risk during the trial.
• People with known reasons why they cannot receive either of the study treatments (confirm with trial site).
• People whose wound shows signs of active infection that requires treatment with antiseptics or antibiotics.

Important: Always verify eligibility with the trial site directly before applying.