Efficacy of matico (Buddleja globosa H.) on healing wounds and ulcers

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38989659

Enrollment

182

Registered

2014-03-26

Start date

2013-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds and ulcers healing Skin and Connective Tissue Diseases Wounds and ulcers healing

Interventions

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 conv

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026