None listed
Conditions
Brief summary
Vitamin C plays an important role in wound healing and half of patients with diabetes-related foot ulcers (DFU) are reported to have low vitamin C levels. There is a strong association between low vitamin C levels and high levels of amputation in people with DFU. Furthermore, small studies have recently reported vitamin C improved the wound healing of foot ulcers. Therefore, the aim of this study is to determine if consuming an oral vitamin C supplement can improve wound healing in people with DFU. The outcomes of this clinical trial will provide the first strong evidence as to whether vitamin C supplementation can improve the healing of DFU and whether it will be helpful to prevent some of the 4,400 amputations annually in Australia.
Interventions
75 males and females with a diabetes-related foot ulcer will be recruited for this multi-site study and undergo placebo or vitamin C supplementation (oral ingestion of 500 mg ascobic acid per capsule, two capsules per day for eight weeks) in a double-blind, randomised manner. Patients will be provided with 8 weeks of either vitamin C or placebo capsules in identical opaque sealed bottles and adherence will be assessed via bottle returns. All researchers involved in the assessments and clinical
75 males and females with a diabetes-related foot ulcer will be recruited for this multi-site study and undergo placebo or vitamin C supplementation (oral ingestion of 500 mg ascobic acid per capsule, two capsules per day for eight weeks) in a double-blind, randomised manner. Patients will be provided with 8 weeks of either vitamin C or placebo capsules in identical opaque sealed bottles and adherence will be assessed via bottle returns. All researchers involved in the assessments and clinical care staff along with the patients will be blinded to the group allocation with all participants continuing to receive usual standard of care throughout the trial. All outcome measures will be conducted at the beginning (baseline) and then at eight weeks of treatment. Outcome measures for wound healing will also be recorded at fortnightly visits to the clinic during the eight week treatment period. The trial will conclude for each patient at eight weeks or beforehand if the ulcer has 100% healed or if the patient undergoes amputation or withdraws consent.
80 males and females with a diabetes-related foot ulcer will be recruited for this multi-site study and undergo placebo or vitamin C supplementation (oral ingestion of 500 mg ascorbic acid per capsule, two capsules per day for eight weeks) in a double-blind, randomised manner. Patients will be provided with 8 weeks of either vitamin C or placebo capsules in identical opaque sealed bottles and adherence will be assessed via bottle returns. All researchers involved in the assessments and clinical
80 males and females with a diabetes-related foot ulcer will be recruited for this multi-site study and undergo placebo or vitamin C supplementation (oral ingestion of 500 mg ascorbic acid per capsule, two capsules per day for eight weeks) in a double-blind, randomised manner. Patients will be provided with 8 weeks of either vitamin C or placebo capsules in identical opaque sealed bottles and adherence will be assessed via bottle returns. All researchers involved in the assessments and clinical care staff along with the patients will be blinded to the group allocation with all participants continuing to receive usual standard of care throughout the trial. All outcome measures will be conducted at the beginning (baseline) and then at eight weeks of treatment. Outcome measures for wound healing will also be recorded at fortnightly visits to the clinic during the eight week treatment period. The trial will conclude for each patient at eight weeks or beforehand if the ulcer has 100% healed or if the patient undergoes amputation or withdraws consent.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (greater than or equal to 18years old) with either type 1 or type 2 diabetes who present to the high risk foot service with a current foot ulcer will be eligible to be included into the study.
Exclusion criteria
(i) inability to provide informed consent; (ii) already being treated with a vitamin C supplement; (iii) already proceeding to amputation following first visit; (iv) hemochromatosis; (v) people on dialysis or proceeding to dialysis following first visit; (vi) injuries arising from prolonged hospitalization or immobility (i.e. pressure sores)
Outcome results
None listed