Condition category
Skin and Connective Tissue Diseases
Date applied
18/10/2013
Date assigned
26/03/2014
Last edited
26/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sandro Bustamante

ORCID ID

Contact details

Phytopharmacology Lab
Molecular and Clinic Pharmacology Program – ICBM
University of Chile - School of Medicine
P.O.Box 70.000
Independencia
Santiago
8380453
Chile

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SA12I2322

Study information

Scientific title

Efficacy of matico (Buddleja globosa H.) on healing wounds and ulcers: a randomized, comparative, open-label 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

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

Study design

Randomized comparative open-label study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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 2–6 (weeks 2–6): Current medical status, physical examination, wound/ulcer evaluation and data recording. Healing protocol according to study branch.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2013

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

182

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

Trial participating centre

Phytopharmacology Lab
Santiago
8380453
Chile

Sponsor information

Organisation

National Commission for Scientific and Technological Research (CONICYT) (Chile)

Sponsor details

National Fund for Research and Development in Health (FONIS)
Canadá #273
Providencia
Santiago
7500788
Chile
+56 (0)2 23654400
schandia@conicyt.cl

Sponsor type

Government

Website

http://www.conicyt.cl/fonis/

Funders

Funder type

Government

Funder name

National Commission for Scientific and Technological Research (CONICYT) (Chile) – National Fund for Research and Development in Health (FONIS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes