Trial Outcomes & Findings for Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers (NCT NCT00393510)

NCT ID: NCT00393510

Last Updated: 2010-07-13

Results Overview

The number of successful limb rescued (without amputation).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2010-07-13

Participant Flow

Apr 2002 to Apr 2006, Orthopaedic Department, Prince of Wales Hospital, HK Apr 2002 to Apr 2006, Orthopaedic Department, Kwong Wah Hospital, HK

Liver Function and Renal Function test normal. Patients suffering from serious cardiac and renal deficiencies were excluded from the study because of safety measure.

Participant milestones

Measure	Traditional Chinese Medicine 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.	Placebo Placebo was made with starch and colouring materials. Given to patient orally twice a day
Overall Study STARTED	40	40
Overall Study COMPLETED	37	31
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Measure	Traditional Chinese Medicine 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.	Placebo Placebo was made with starch and colouring materials. Given to patient orally twice a day
Overall Study Physician Decision	3	9

Baseline Characteristics

Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Baseline characteristics by cohort

Measure	Traditional Chinese Medicine n=40 Participants 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.	Placebo n=40 Participants Placebo was made with starch and colouring materials. Given to patient orally twice a day	Total n=80 Participants Total of all reporting groups
Age Continuous	66.3 years STANDARD_DEVIATION 12.6 • n=5 Participants	68.5 years STANDARD_DEVIATION 11.1 • n=7 Participants	67.4 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment Hong Kong	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

The number of successful limb rescued (without amputation).

Outcome measures

Measure	Traditional Chinese Medicine n=40 Participants 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.	Placebo n=40 Participants Placebo was made with starch and colouring materials. Given to patient orally twice a day
Number of Participants With Limb Salvage	37 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline and 4 week

The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.

Outcome measures

Measure	Traditional Chinese Medicine n=40 Participants 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.	Placebo n=40 Participants Placebo was made with starch and colouring materials. Given to patient orally twice a day
Tumour Necrosis Factor-alpha Levels in Serum Baseline	48 pg/mL Standard Deviation 116	44 pg/mL Standard Deviation 83
Tumour Necrosis Factor-alpha Levels in Serum Week 4	28 pg/mL Standard Deviation 62	39 pg/mL Standard Deviation 64

SECONDARY outcome

Timeframe: 24 week

Time taken for maturation of granulation to enable skin grafting.

Outcome measures

Measure	Traditional Chinese Medicine n=37 Participants 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.	Placebo n=31 Participants Placebo was made with starch and colouring materials. Given to patient orally twice a day
Time of Ulcer Healing	5.9 Weeks Standard Deviation 1.4	9.2 Weeks Standard Deviation 1.9

Adverse Events

Traditional Chinese Medicine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Leung Ping Chung

Institute of Chinese Medicine, Chinese University of Hong Kong

Phone: (852)2252 8863

Email: pingcleung@cuhk.edu.hk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place