Diabetic foot ulcer
Conditions
Interventions
Two groups:Chinese herbal medicine containing 2 herbs (Radix Rehmanniae and Radix Astragali) vs placebo for 6 months
Sponsors
Institute of Chinese Medicine
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Type 1 or 2 diabetic subjects with chronic foot ulcers of mild to moderate degree; 2. Male or female patients attending Podiatry Clinics at the hospitals of the New Territories East Cluster; 3. Age of 20 years or above?All patients should be on stable dose of medication 4 weeks prior to enrolment; 4. Capable of giving written informed consent; 5. If the patient is a woman of child-bearing potential, she must agree to use adequate method of contraception throughout the study period, unless surgically sterilized. Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Patients with end-stage renal disease as defined by the need for dialysis or on renal replacement program; 2. Pregnancy, breast feeding, or patient has plans of becoming pregnant during the study period; 3. Known allergy to TCM; 4. Patients with active gastroinestinal bleeding; 5. Class III or IV congestive heart failure as classified by NYHA; 6. Significant cardiovascular disease within 3 months of enrolment including acute coronary syndrome, cardiac revascularization procedure, transient ischemic attack and cerebrovascular accident; 7. HbA1c >=10%; 8. Severe liver function impairment (>=3* ULN of ALT) and renal impairment (eGFR <15 ml/min/1.73 m2); 9. Investigation drugs within 30 days of enrollment; 10. Patient taking TCM in the 8 weeks prior to enrollment into the study; 11. Any other medical condition considered unsuitable for enrolment by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution of foot ulcer based on PEDIS;Time to failure of intensive ambulatory treatment by medical team and podiatrist, requiring referral to orthopaedic/surgical teams; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of hospital admissions;Total hospitalization days;Changes in metabolic and inflammatory parameters including: -HbA1c -Fasting plasma glucose - Fasting lipid profiles -Urine albumin/creatinine ratio -Inflammatory markers– high sensitive C-reactive protein, white blood cell count, TNF-alpha;Genomic profile: Blood samples (pre- and post-treatment) for quantitation of RNA of inflammatory cytokines and growth factors;Quality of life: SF-36; | — |
Contacts
Public ContactDr Risa Ozaki
Outcome results
None listed