Phase 2
N=80
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Diabetic Foot Ulcer · Amputation
Bottom Line
View on ClinicalTrials.gov: NCT00393510 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Number of Participants With Limb Salvage — 37; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TCM (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Chinese University of Hong Kong
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Limb Salvage |
37; 31 | — |
| SECONDARY Tumour Necrosis Factor-alpha Levels in Serum |
48; 44; 28; 39 | — |
| SECONDARY Time of Ulcer Healing |
5.9; 9.2 | — |
Summary
Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation.
Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.
Eligibility Criteria
Inclusion Criteria
- Well Controlled diabetic state
- Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled.
- Good glycaemic control
Exclusion Criteria
- Pregnant women and women at risk of conception
- Patients taking digitalis glycosides
- Patients with abnormal liver function tests
- Patients with plasma creatinine great then 150 umol/l or unstable renal function
- Poorly controlled Diabetes Mellitus
- Uncontrolled infection
- History of adverse reaction to herbal medicine
- Unstable medical conditions
- Non-compliance with regime
Data sourced from ClinicalTrials.gov (NCT00393510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.