Efficacy of matico (Buddleja globosa H.) on healing wounds and ulcers
| ISRCTN | ISRCTN38989659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38989659 |
| Secondary identifying numbers | SA12I2322 |
- Submission date
- 18/10/2013
- Registration date
- 26/03/2014
- Last edited
- 26/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Wounds and ulcers are a major issue for health care systems and for individuals.
The convention treatment (CT) is applying a tulle dressing over wound/ulcers on a weekly basis. As a result 80% of type-1 or type-2 wound/ulcers heal in six weeks.
Matico (Buddleja globosa H.) is a shrub from Chile recognized by the Chilean Government Health Care System as a medicinal plant that can help heal wounds and ulcers. There has been no previous studies to demonstrate its therapeutic efficacy and safety for external and internal lesions. If matico is a medicinal plant with healing properties, we expect a 30% improvement in the healing process, a significant reduction in cost, and the same or less adverse reaction compared to CT alone and an improved quality of life. The aim of this study is to assess how well an extract of matico works on type-1 or type-2 wound/ulcers.
Who can participate?
Men and women aged between 18 and 75, with type-1 or -2 wounds/ulcers, and body mass index between 20 and 35.
What does the study involve?
Participants are randomly allocated to receive conventional treatment (CT) or CT + matico cream.
What are the possible benefits and risks of participating?
The healing process is faster and cheaper.
Where is the study run from?
Primary Care Centre, Santiago, Chile
When is the study starting and how long is it expected to run for?
The study is expected to start in August 2013 and to recruit participants for one year.
Who is funding the study?
This study is fully funding by the National Commission for Scientific and Technological Research (CONICYT) through its National Fund for Research and Development in Health (FONIS) program (Chile).
Who is the main contact?
Prof. Sandro Bustamante
Contact information
Scientific
Phytopharmacology Lab
Molecular and Clinic Pharmacology Program ICBM
University of Chile - School of Medicine
P.O.Box 70.000
Independencia
Santiago
8380453
Chile
Study information
| Study design | Randomized comparative open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of matico (Buddleja globosa H.) on healing wounds and ulcers: a randomized, comparative, open-label study |
| Study acronym | BUDDLEJA |
| Study hypothesis | Conventional treatment plus topical matico (Buddleja globosa H.) is more effective to heal type 1 or 2 wounds and ulcers than conventional treatment alone. |
| Ethics approval(s) | 1. Ethics Committee of Investigation on Human Beings, University of Chile - School of Medicine, 09/04/2012 2. Ethics Committee Family Health Centre EEF, 28/08/2013 |
| Condition | Wounds and ulcers healing |
| Intervention | Visit 1 (week 1): 1. Inclusion/exclusion criteria flowchart, informed consent. 2. Baseline medical history, current medical status, physical examination. Participant randomly allocated to receive conventional treatment (CT) or CT + matico cream. 3. Wound/ulcer evaluation and data recording. Healing protocol according to study branch. Visits 26 (weeks 26): Current medical status, physical examination, wound/ulcer evaluation and data recording. Healing protocol according to study branch. |
| Intervention type | Other |
| Primary outcome measure | 1. Efficacy to heal type 1 or 2 wounds and ulcers 2. Time to heal type 1 or 2 wounds and ulcers 3. Security and adverse reactions 4. Medication compliance 5. Treatment cost for health system/patient Timepoints for all primary outcomes will be measured at baseline, and weekly from week 1 to 6. |
| Secondary outcome measures | 1. Efficacy - ten parameters wil be used to evaluate healing efficacy; each parameter will be scored from 1 to 4 points, as is shown below: 1.1. Wound/ulcer visual aspect: 1.1.1. Eritematosus, one point 1.1.2. Redish, two points 1.1.3. Yellowish/pale, three points 1.1.4. Necrotic, four points 1.2. Wound/ulcer longer diameter (measured with a standard sterile plastic flexible ruler): 1.2.1. 0.0 to 1.0 cm, one point 1.2.2. 1.1 to 3.0 cm, two points 1.2.3. 3.1 to 6.0 cm, three points 1.2.4 6.1 cm or bigger, four points 1.3. Wound/ulcer depth (measured with a standard sterile plastic flexible ruler): 1.3.1. 0.0 cm, one point 1.3.2. 0.1 to 1.0 cm, two points 1.3.3. 1.1 to 3.0 cm, three points 1.3.4. 3.1 cm or bigger, four points 1.4. Wound/ulcer exudate quantity: 1.4.1. No, one point 1.4.2. Scarce, two points 1.4.3. Mild, three points 1.4.4. Plentiful, four points 1.5. Wound/ulcer exudate quality: 1.5.1. No, one point 1.5.2. Opaque, two points 1.5.3 Turbid, three points 1.5.4. Purulent, four points 1.6. Wound/ulcer necrotic tissue: 1.6.1. No, one point 1.6.2. Less than 25%, two points 1.6.3. 25% to 50%, three points 1.6.4. More than 50%, four points 1.7. Wound/ulcer granulatory tissue: 1.7.1. 100% to 75%, one point 1.7.2. 75% to 50%, two points 1.7.3. 50% to 25%, three points 1.7.4. 25% or less, four points 1.8. Wound/ulcer oedema: 1.8.1. No, one point 1.8.2. +, two points 1.8.3. ++, three points 1.8.4. +++, four points 1.9. Wound/ulcer pain: 1.9.1. 0 to 1, one point 1.9.2. 2 to 3, two points 1.9.3. 4 to 6, three points 1.9.4. 7 to 10, four points 1.10. Wound/ulcer surrounding skin parameters: 1.10.1. Normal, one point 1.10.2. Desquamated, two points 1.10.3. Eritematosus, three points 1.10.4. Macerated, four points Total score qualify type of wound/ulcer: 10 15 points, type-1 16 21 points, type-2 22 27 points, type-3 28 40 points, type-4 2. Time to heal: 2.1. Number of days to get healthy tissue 3. Security and adverse reaction: 3.1. Qualitative description 3.2. Quantitative description 4. Medication compliance: It is considered compliant if he/she attends at least five out of six programmed visits of healing process 5. Treatment cost: 5.1. Supplies expenses for health care system 5.2. Supplies and other expenses for participant Timepoints for all secondary outcomes will be measured at baseline, and weekly from week 1 to 6. |
| Overall study start date | 01/08/2013 |
| Overall study end date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 182 |
| Participant inclusion criteria | 1. Men and women aged 18 to 75 years old 2. Type 1 or 2 wounds and ulcers 3. Body mass index between 20 and 35 |
| Participant exclusion criteria | 1. Either allergy to matico shrub (Buddleja globosa H.) or to any constituents of matico extract phytomedicine 2. Diagnostic of allergic/irritative dermatitis 3. Any vascular disease or varicose ulcer (including diabetic foot) 4. Skin neoplasia 5. Wounds/ulcers caused by radiation, or cytostatic/steroid drugs |
| Recruitment start date | 01/08/2013 |
| Recruitment end date | 30/06/2014 |
Locations
Countries of recruitment
- Chile
Study participating centre
8380453
Chile
Sponsor information
Government
National Fund for Research and Development in Health (FONIS)
Canadá #273
Providencia
Santiago
7500788
Chile
| Phone | +56 (0)2 23654400 |
|---|---|
| schandia@conicyt.cl | |
| Website | http://www.conicyt.cl/fonis/ |
"ROR" |
https://ror.org/02ap3w078 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
