Acetic Acid in Cutaneous Ulcers. Randomized Controlled Trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Consorci Sanitari De L'Alt Penedes I Garraf

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

27 Apr 2025 → ongoing

Decision date (initial)

2023-10-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To study the efficacy of topical treatment with acetic acid versus control to improve healing of skin ulcers with biofilm, in terms of change in ulcer area from baseline (percentage), at 8 weeks of treatment.

Secondary objectives 7

1. To study the efficacy of intervention versus control in terms of the proportion of patients with ulcer healing at 4 weeks.
2. To study the efficacy of intervention versus control in terms of the proportion of patients with ulcer healing at 12 weeks.
3. To study the efficacy of intervention versus control in terms of time to ulcer healing
4. To study the efficacy of the intervention versus the control in terms of biofilm improvement at 8 weeks.
5. To study whether there are differences between branches in the length of hospital stay.
6. To study the safety of the intervention compared to the control, in terms of the number of adverse reactions associated with the treatment in each branch of the study.
7. Evaluate the care expenditure associated with each arm of study.

Conditions and MedDRA coding

Skin ulcer

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients over 18 years of age.
2. Continuous care (hospital or outpatient) in one of the study center units.
3. Presence of skin ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
4. Anticipation of treatment and follow-up of the ulcer (at least 8 weeks) at the study center.
5. Possibility of collaborating in the necessary evaluations.
6. Informed consent for study inclusion, own or by the legal representative of the participant.

Exclusion criteria 2

1. Participants diagnosed with any of the following pathologies: a) Ulcers with exposed bone tissue. b) Ulcers of neoplastic origin c) Ulcers older than 18 months
2. Participation in another clinical trial that involves an experimental intervention during the period of this trial and/or establishes a periodicity of visits that is incompatible with this trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in ulcer area (percentage of baseline area) 8 weeks after start of treatment

Secondary endpoints 7

1. Percentage of participants with ulcer healing 4 weeks after starting treatment
2. Percentage of participants with ulcer healing at 12 weeks from the start of treatment.
3. Time (days) to ulcer healing from start of treatment.
4. Time (days) until hospital discharge from the CSAPG, according to the clinical history record.
5. Changes in the wound bed at 8 weeks according to section 6 of the RESVECH 2.0 scale
6. Number of adverse reactions associated with the treatment, collected from the clinical history.
7. Healthcare expense associated with each branch of the study, using the center's billing data associated with the use of resources by the insured

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Consorci Sanitari De L'Alt Penedes I Garraf

Sponsor organisation

Consorci Sanitari De L'Alt Penedes I Garraf

Address

Avinguda De L Espirall 61

City

Vilafranca Del Penedes

Postcode

08720

Country

Spain

Scientific contact point

Organisation

Consorci Sanitari De L'Alt Penedes I Garraf

Contact name

Àrea de Recerca

Public contact point

Organisation

Consorci Sanitari De L'Alt Penedes I Garraf

Contact name

Àrea de Recerca

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications