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Skin Ulcers Treatment With an Handicraft Topical Device

Primary Purpose

Foot Ulcer, Varicose Ulcer

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

drenovac handcrafted

Healing

About this trial

This is an interventional treatment trial for Foot Ulcer focused on measuring Diabetic foot ulcer, Foot care, Wound management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

drenovac handcrafted

Healing

Arm Description

Patients treatment with the handicraft topical device negative pressure therapy Economic craft

Patients who were managed with traditional "conservative treatment".

Outcomes

Primary Outcome Measures

Presence of granulation tissue in skin ulcers.

Presence of granulation tissue in 50% of the wound

Secondary Outcome Measures

Leukocyte less than 11,000 mm3.

Temperature

less than 38 ° C temperature.

Breathing Rate

less than 20 rpm breathing rate.

Heart Rate

lower heart rate 90 bpm.

Full Information

NCT ID

NCT02512159

First Posted

March 12, 2015

Last Updated

July 29, 2015

Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

Instituto Mexicano del Seguro Social

1. Study Identification

Unique Protocol Identification Number

NCT02512159

Brief Title

Skin Ulcers Treatment With an Handicraft Topical Device

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

Instituto Mexicano del Seguro Social

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Ulcer, Varicose Ulcer

Keywords

Diabetic foot ulcer, Foot care, Wound management

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

drenovac handcrafted

Arm Type

Experimental

Arm Description

Patients treatment with the handicraft topical device negative pressure therapy Economic craft

Arm Title

Healing

Arm Type

Active Comparator

Arm Description

Patients who were managed with traditional "conservative treatment".

Intervention Type

Procedure

Intervention Name(s)

drenovac handcrafted

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Healing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Presence of granulation tissue in skin ulcers.

Description

Presence of granulation tissue in 50% of the wound

Time Frame

10 days

Secondary Outcome Measure Information:

Title

Leukocyte less than 11,000 mm3.

Description

Leukocyte less than 11,000 mm3.

Time Frame

10 days

Title

Temperature

Description

less than 38 ° C temperature.

Time Frame

10 days

Title

Breathing Rate

Description

less than 20 rpm breathing rate.

Time Frame

10 days

Title

Heart Rate

Description

lower heart rate 90 bpm.

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fany Guadalupe Pat Espadas, MCs

Organizational Affiliation

IMSS

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Israel Augusto González González, Dr.

Organizational Affiliation

IMSS

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Luis Sandoval Jurado, PhD

Organizational Affiliation

IMSS

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ma. Valeria Jiménez Baéz, PhD

Organizational Affiliation

IMSS

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

27822727

Citation

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.

Results Reference

derived

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Skin Ulcers Treatment With an Handicraft Topical Device

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