Foot UlcerPhase 4NCT02512159
Skin Ulcers Treatment With an Handicraft Topical Device
A Phase 4 study testing drenovac handcrafted and Healing in people with Foot Ulcer and Varicose Ulcer, run by Coordinación de Investigación en Salud, Mexico.
Trial summary
The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Ulcer, Varicose Ulcer
- What is being tested?
- drenovac handcrafted and Healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo.
- Patients of both sexes.
- Patients over 18 years.
- Patients that have basic laboratory at admission (complete blood count with differential).
- Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.
Who cannot join
- Hemodynamically unstable patients.
- Patients with septic shock from any source.
- Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.
- Patients with secondary cutaneous ulcer enteral fistula.
- Patients with cutaneous ulcer or cancer tumors.
- Patients with cutaneous ulcer with active bleeding.
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- Patients with cutaneous ulcer necrosis.
- Patients with cutaneous ulcer leishmania, insect bite.
- Patients with cutaneous ulcer burns.
- Patients who do not accept their participation in the study through informed consent.
About this study
Official title: Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb
The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.
Read the detailed description
The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment
- Conditions
- Foot Ulcer, Varicose Ulcer
- Being tested
- drenovac handcrafted, Healing
- Keywords
- Diabetic foot ulcer, Foot care, Wound management
- Medical subject headings
- Foot Ulcer, Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drenovac handcraftedProcedure or surgery
under local anesthesia, sepsis and antisepsis, place sterile field, prepared area go out all devitalized or necrotic tissue using liquid soap surgical and irrigation back saline 0.9%. We introduce a device to distribute the negative pressure or vacuum on ulcer; conducted margins make recommendations 5-12 mm over the edge of the wound, applying negative pressure or vacuum retracted sponges, likewise for the spare fewer gauze was placed Sterile adhesive film covering the defect to seal the system cover adequately the probe output nelaton not to submit drain the system. Connect the probe to the sterile nelaton this hose and a suction system with pressure gauge, pressure -80-125 mmHg. Change it every 72 hours.
HealingProcedure or surgery
Were handled as follows:
- Under local anesthesia, prior asepsis and antisepsis of the skin ulcer with iodinepovidone sterile fields are placed, we proceeded to debridement of all necrotic tissue or devitalized then a cure with liquid soap surgery was performed and was irrigated with 1000 cc of solution physiological 0.9%, and finally the ulcer was covered with sterile gauze.
- healing of skin ulcers were performed every 24 hours.
- the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables.
| Study group | Role | What they receive |
|---|---|---|
| drenovac handcrafted | Experimental | Patients treatment with the handicraft topical device negative pressure therapy Economic craft Receives: Procedure: drenovac handcrafted |
| Healing | Active comparator | Patients who were managed with traditional "conservative treatment". Receives: Procedure: Healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of granulation tissue in skin ulcers.
Presence of granulation tissue in 50% of the wound
Measured: 10 days
Secondary outcomes (4)
Leukocyte less than 11,000 mm3.
Leukocyte less than 11,000 mm3.
Measured: 10 days
Temperature
less than 38 ° C temperature.
Measured: 10 days
Breathing Rate
less than 20 rpm breathing rate.
Measured: 10 days
Heart Rate
lower heart rate 90 bpm.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor
- Investigators
- Fany Guadalupe Pat Espadas, MCs, Principal investigator, IMSSIsrael Augusto González González, Dr., Study chair, IMSSLuis Sandoval Jurado, PhD, Study director, IMSSMa. Valeria Jiménez Baéz, PhD, Study chair, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512159
- Sponsor's protocol ID
- 2014-2301-12
- Status last verified
- Feb 2014
- First submitted
- 12 Mar 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez IG, Angel MA, Baez MV, Ruiz Flores B, de Los Angeles Martinez Ferretiz M, Woolf SV, Lopez I, Sandoval-Jurado L, Pat-Espadas FG, Cruz AA, Delgado AT. Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial. World J Surg. 2017 Feb;41(2):386-393. doi: 10.1007/s00268-016-3782-9.
PubMed 27822727
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb
- ClinicalTrials.gov ID
- NCT02512159
- Acronym / sponsor ID
- 2014-2301-12
- Conditions
- Foot Ulcer, Varicose Ulcer
- Keywords
- Diabetic foot ulcer, Foot care, Wound management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.
Detailed description
The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drenovac handcrafted | Experimental | Procedure: drenovac handcraftedPatients treatment with the handicraft topical device negative pressure therapy Economic craft |
| Healing | Active comparator | Procedure: HealingPatients who were managed with traditional "conservative treatment". |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo.
- Patients of both sexes.
- Patients over 18 years.
- Patients that have basic laboratory at admission (complete blood count with differential).
- Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.
Key exclusion criteria (10 listed)
- Hemodynamically unstable patients.
- Patients with septic shock from any source.
- Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.
- Patients with secondary cutaneous ulcer enteral fistula.
- Patients with cutaneous ulcer or cancer tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drenovac handcraftedunder local anesthesia, sepsis and antisepsis, place sterile field, prepared area go out all devitalized or necrotic tissue using liquid soap surgical and irrigation back saline 0.9%. We introduce a device to distribute the negative pressure or vacuum on ulcer; conducted margins make recommendations 5-12 mm over the edge of the wound, applying negative pressure or vacuum retracted sponges, likewise for the spare fewer gauze was placed Sterile adhesive film covering the defect to seal the system cover adequately the probe output nelaton not to submit drain the system. Connect the probe to the sterile nelaton this hose and a suction system with pressure gauge, pressure -80-125 mmHg. Change it every 72 hours. | Procedure or surgery | drenovac handcrafted |
| HealingWere handled as follows: 1. Under local anesthesia, prior asepsis and antisepsis of the skin ulcer with iodinepovidone sterile fields are placed, we proceeded to debridement of all necrotic tissue or devitalized then a cure with liquid soap surgery was performed and was irrigated with 1000 cc of solution physiological 0.9%, and finally the ulcer was covered with sterile gauze. 2. healing of skin ulcers were performed every 24 hours. 3. the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables. | Procedure or surgery | Healing |
Primary outcome
Presence of granulation tissue in skin ulcers.
Time frame: 10 days
Presence of granulation tissue in 50% of the wound
4 secondary outcomes
Leukocyte less than 11,000 mm3.
Time frame: 10 days
Temperature
Time frame: 10 days
Breathing Rate
Time frame: 10 days
Heart Rate
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Derived from this study: PubMed 27822727Gonzalez IG, Angel MA, Baez MV, Ruiz Flores B, de Los Angeles Martinez Ferretiz M, Woolf SV, Lopez I, Sandoval-Jurado L, Pat-Espadas FG, Cruz AA, Delgado AT. Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial. World J Surg. 2017 Feb;41(2):386-393. doi: 10.1007/s00268-016-3782-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fany Guadalupe Pat Espadas, MCs principal investigator
IMSS
Israel Augusto González González, Dr. study chair
IMSS
Luis Sandoval Jurado, PhD study director
IMSS
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing drenovac handcrafted and Healing in people with Foot Ulcer and Varicose Ulcer, run by Coordinación de Investigación en Salud, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of granulation tissue in skin ulcers. (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.