Diabetic Foot Ulcer, Amputation
Conditions
Keywords
Diabetic Foot Ulcer, Traditional Chinese Medicine
Brief 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.
Interventions
DRUGTCM
The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The formula consisted of 12 herbs, viz: Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae
DRUGPlacebo
Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The placebo was made with starch and colouring materials.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Limb Salvage | 24 weeks | The number of successful limb rescued (without amputation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumour Necrosis Factor-alpha Levels in Serum | Baseline and 4 week | The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level. |
| Time of Ulcer Healing | 24 week | Time taken for maturation of granulation to enable skin grafting. |
Countries
China
Participant flow
Recruitment details
Apr 2002 to Apr 2006, Orthopaedic Department, Prince of Wales Hospital, HK Apr 2002 to Apr 2006, Orthopaedic Department, Kwong Wah Hospital, HK
Pre-assignment details
Liver Function and Renal Function test normal. Patients suffering from serious cardiac and renal deficiencies were excluded from the study because of safety measure.
Participants by arm
| Arm | Count |
|---|---|
| Traditional Chinese Medicine 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day. | 40 |
| Placebo Placebo was made with starch and colouring materials. Given to patient orally twice a day | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 9 |
Baseline characteristics
| Characteristic | Traditional Chinese Medicine | Placebo | Total |
|---|---|---|---|
| Age Continuous | 66.3 years STANDARD_DEVIATION 12.6 | 68.5 years STANDARD_DEVIATION 11.1 | 67.4 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment Hong Kong | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 25 Participants | 22 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Number of Participants With Limb Salvage
The number of successful limb rescued (without amputation).
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Traditional Chinese Medicine | Number of Participants With Limb Salvage | 37 Participants |
| Placebo | Number of Participants With Limb Salvage | 31 Participants |
Secondary
Time of Ulcer Healing
Time taken for maturation of granulation to enable skin grafting.
Time frame: 24 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Chinese Medicine | Time of Ulcer Healing | 5.9 Weeks | Standard Deviation 1.4 |
| Placebo | Time of Ulcer Healing | 9.2 Weeks | Standard Deviation 1.9 |
Secondary
Tumour Necrosis Factor-alpha Levels in Serum
The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.
Time frame: Baseline and 4 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Chinese Medicine | Tumour Necrosis Factor-alpha Levels in Serum | Baseline | 48 pg/mL | Standard Deviation 116 |
| Traditional Chinese Medicine | Tumour Necrosis Factor-alpha Levels in Serum | Week 4 | 28 pg/mL | Standard Deviation 62 |
| Placebo | Tumour Necrosis Factor-alpha Levels in Serum | Baseline | 44 pg/mL | Standard Deviation 83 |
| Placebo | Tumour Necrosis Factor-alpha Levels in Serum | Week 4 | 39 pg/mL | Standard Deviation 64 |