Skin Ulcers Treatment With an Handicraft Topical Device

Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512159
• Other study ID #: 2014-2301-12
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2015
• Last updated: July 29, 2015
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2014
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Ulcer
• Skin Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Procedure:
• drenovac 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.
• Healing
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Instituto Mexicano del Seguro Social

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of granulation tissue in skin ulcers.	Presence of granulation tissue in 50% of the wound	10 days	No
Secondary	Leukocyte less than 11,000 mm3.	Leukocyte less than 11,000 mm3.	10 days	No
Secondary	Temperature	less than 38 ° C temperature.	10 days	No
Secondary	Breathing Rate	less than 20 rpm breathing rate.	10 days	No
Secondary	Heart Rate	lower heart rate 90 bpm.	10 days	No