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Skin Ulcers Treatment With an Handicraft Topical Device

Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02512159
Enrollment
144
Registered
2015-07-30
Start date
2014-03-31
Completion date
2015-01-31
Last updated
2015-07-30

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

Conditions

Foot Ulcer, Varicose Ulcer

Keywords

Diabetic foot ulcer, Foot care, Wound management

Brief 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.

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

Interventions

PROCEDUREdrenovac handcrafted

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.

PROCEDUREHealing

Were 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.

Sponsors

Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Coordinación de Investigación en Salud, Mexico
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. 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. 2. Patients of both sexes. 3. Patients over 18 years. 4. Patients that have basic laboratory at admission (complete blood count with differential). 5. Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.

Exclusion criteria

1. Hemodynamically unstable patients. 2. Patients with septic shock from any source. 3. Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure. 4. Patients with secondary cutaneous ulcer enteral fistula. 5. Patients with cutaneous ulcer or cancer tumors. 6. Patients with cutaneous ulcer with active bleeding. 7. Patients with cutaneous ulcer necrosis. 8. Patients with cutaneous ulcer leishmania, insect bite. 9. Patients with cutaneous ulcer burns. 10. Patients who do not accept their participation in the study through informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Presence of granulation tissue in skin ulcers.10 daysPresence of granulation tissue in 50% of the wound

Secondary

MeasureTime frameDescription
Leukocyte less than 11,000 mm3.10 daysLeukocyte less than 11,000 mm3.
Temperature10 daysless than 38 ° C temperature.
Breathing Rate10 daysless than 20 rpm breathing rate.
Heart Rate10 dayslower heart rate 90 bpm.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026