None listed
Conditions
Brief summary
The aim is to perform a randomised, double-blind, inactive-comparator-controlled trial of vitamin C and zinc for the treatment of foot ulcers in people attending multi-disciplinary high-risk foot ulcer clinics. Our overall hypothesis is that treating people who have chronic foot ulcers with vitamin C and/or zinc will improve ulcer healing and thereby improve quality of life, prevent osteomyelitis, decrease amputations and will be safe, highly cost-effective and widely implementable. Patients will be treated for 8 weeks and followed up until complete ulcer healing, amputation, or a minimum of 12 weeks if not fully healed before. Patients will have a blood test for serum vitamin C and zinc at baseline, accompanied by any usual tests required by the foot ulcer clinics. After this baseline visit, patients will otherwise have usual care at the foot ulcer clinic, except for taking their assigned tablets. After 4 weeks their blood results for zinc and vitamin C will be made available. If deficient, they will receive both tablets for their deficiency. This will ensure we offer all people who are identified as deficient treatment but maintain blinding to their original 4 weeks of treatment. At 8 weeks or the closest visit, people will have their blood vitamin C and zinc re-tested. They will then be followed until complete ulcer healing, amputation or a minimum of 12 weeks if not healed before.
Interventions
2x2 factorial design randomised, double blinded controlled trial of supplementation with vitamin C and/or zinc vs placebo for healing of foot ulcers in patients attending a high risk foot service
Daily, oral capsule, 500mg of vitamin C and/or 30mg of zinc for 60 days. Empty packet will be returned to treating team and will be used to assess compliance. In people in whom baseline levels are low for either vit C or zinc, from the return of the blood test result of vitamin C and zinc (returned at 4
2x2 factorial design randomised, double blinded controlled trial of supplementation with vitamin C and/or zinc vs placebo for healing of foot ulcers in patients attending a high risk foot service Daily, oral capsule, 500mg of vitamin C and/or 30mg of zinc for 60 days. Empty packet will be returned to treating team and will be used to assess compliance. In people in whom baseline levels are low for either vit C or zinc, from the return of the blood test result of vitamin C and zinc (returned at 4 weeks), they will receive BOTH supplements (so the first 4 weeks of the study remains blinded)
Sponsors
Blacktown Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
New presentation to the high risk foot service at Blacktown Hospital. Only people with a foot ulcer can attend this clinic.
Exclusion criteria
Not a new patient for the clinic Inability to give informed consent Taking vitamin C or zinc supplements within 3 months Unable to take vitamin C /zinc tablets
Outcome results
None listed