Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
|ClinicalTrials.gov Identifier: NCT00393510|
Recruitment Status : Completed
First Posted : October 27, 2006
Results First Posted : July 1, 2010
Last Update Posted : July 13, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer Amputation||Drug: TCM Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment|
|Study Start Date :||November 2000|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
Active Comparator: Traditional Chinese Medicine
12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
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
Placebo Comparator: Placebo
Placebo was made with starch and colouring materials. Given to patient orally twice a day
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.
- Number of Participants With Limb Salvage [ Time Frame: 24 weeks ]The number of successful limb rescued (without amputation).
- Tumour Necrosis Factor-alpha Levels in Serum [ Time Frame: 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 [ Time Frame: 24 week ]Time taken for maturation of granulation to enable skin grafting.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393510
|Department of Orthopaedics & Traumatology, Prince of Wales hospital|
|Hong Kong, China|
|Department of Orthopaedics and Traumatology, Kwong Wah Hospital|
|Hong Kong, China|
|Principal Investigator:||Leung Ping Chung, MD||Dept. of Orthopaedics & Traumatology, CUHK|