The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)

NCT02334241 | Completed

• 1 other identifier: INR 2014-001
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 15

Brief Summary

The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of using Sorbact® dressing technology in addition to best local cares compared to best local cares alone in the management of diabetic foot ulcers

Conditions

Foot Ulcer, Diabetic

Keywords

Sorbact; Best local Cares; DFU

Outcome Measures

Primary Outcomes (1)

• Favourable healing outcome (FHO)

  A FHO is considered to have occurred in a given patient if all the following composite endpoints are met: I. Total wound area (sum of areas of all present wounds on both limbs) has decreased, compared to baseline, by 50% or more at last available evaluation. II. No minor or major amputation decided during the follow-up period. III. No moderate/severe infection of any present wound has been detected during the follow-up period.

  12 weeks

Secondary Outcomes (5)

• Comparative evaluation of each of the items used to define a FHO.

  12 weeks

• Time to reach a 50% total wound area reduction.

  12 weeks

• Comparative evaluation of the number of complete wound closure.

  12 weeks

• Comparative evaluation of total absolute and relative wound area regression and of total wound edge migration (Gilman's formula; sum of the score of each individual ulcer) over 12 weeks (centralized analysis of wound area tracings).

  12 weeks

• Number of local cares requiring instrumental debridement (surgical or sharp debridement).

  12 weeks

Study Arms (2)

Sorbact®

EXPERIMENTAL

The basic Sorbact® presentation is an antimicrobial, non-adhesive absorbent wound dressing. It consists of a highly absorbent hydropolymer matrix with an antimicrobial Sorbact® mesh (Sorbact® acetate fabric coated with dialkyl carbamoyl chloride - DACC) and is covered by a semipermeable polyurethane film.

Device: Sorbact®

Best local cares

ACTIVE COMPARATOR

Dressing requirements in this study have to be consistent with international guidelines.

Device: Best local cares

Interventions

Sorbact® DEVICE

Sorbact® is available in many types and sizes. These different presentations are available allowing management of quite all types of wounds of various anatomical locations, sizes or depths. Application of any of these presentations is allowed and may change during study course according to wound evolution.

Sorbact®

Best local cares DEVICE

Participating centers will provide a list of dressings they planned to use in the best local cares arm. This list must be validated by the study Steering Committee members

Best local cares

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent to participate obtained.
• Male or female patient aged at least 18 years without superior limit.
• Type 1 or 2 diabetes.
• Less than one month HbA1c \<=10%.
• Presence, on at least one foot, of a full-thickness ulcer for at least 4 weeks (location below the malleola).
• Neuropathy confirmed by insensitivity to monofilament (Semmes-Weinstein 5.07 monofilament according to diagnosis criteria presented in appendix 05).
• No ulcer should present a moderate or severe infection at baseline. Concomitant treatment with systemic antibiotics at baseline is accepted if all ulcers meet none of the criteria defining moderate or severe infection.
• All ulcers are appropriately debrided (less than 10% black tissue covering wound area on a colorimetric scale, adequate removal of hyperkeratosis).
• All ulcers are of Grade 1 or 2 of the Wagner classification.
• Ulcers should meet one of the following criteria:
• If only one ulcer is present, its largest diameters has to be ≥1 cm or this ulcer is categorized as grade 2 according to Wagner classification If more than one ulcer is present, the sum of all largest diameters has to be ≥2 cm or one ulcer is categorized as grade 2 according to Wagner classification
• For both legs: ABPI ≥0.6 and \<1.3 AND ankle systolic pressure ≥70 mmHg or systolic toe pressure ≥50 mmHg or TcPo2 ≥30 mmHg (decubitus).
• If ABPI ≥1.3, patent femoral artery inflow should be confirmed by digital angiography, magnetic resonance, or CT angiography or doppler ultrasonography \<6 months before randomization.
• Patient compliant to one of the accepted off-loading system.

You may not qualify if:

• Previous history of major amputation (cf. § 10.3.3.2 for definition) or planned major amputation within the first month after randomization.
• Revascularization procedure of lower leg, or any other treatment (e.g. neurostimulation) of any leg \<8 weeks before randomization.
• Patient unable to be treated with one of the accepted type of off-loading system.
• Active Charcot foot.
• Presence of any ulcer with evidence of skin cancer.
• Presence of another chronic wound (i.e. present for 4 weeks or more) not involving the foot or involving the foot but extending above malleolus.
• Patient suffering from any known active malignancy, other than basal-cell carcinoma and cervical carcinoma in situ, requiring any general, local, surgical or radiation therapy.
• Patient suffering from severe morbid obesity (BMI ≥50 kg/m2).
• Severe hypertension with systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg (measured at two occasions separated by a 4 week period in a patient sitting for at least 5 min).
• Patient with a severe comorbid disorder, not expected to survive more than 12 months
• Acute cardiovascular events (e.g. myocardial infarction, stroke, recent coronary intervention) within 3 months before randomisation
• Known intolerance to the tested medical device.

Sponsors & Collaborators

• INRESA Pharma: lead
• RCTs: collaborator

Study Sites (15)

Faculty of Medicine MU a FH St. Ann Brno

Brno, 656 91, Czechia

Location

Cardiologic and pediatric ambulance s.r.o.

Ostrava-vitkovice, 703 00, Czechia

Location

Institute for Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

Podiatrie - Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

Prague, 169 02, Czechia

Location

Bulovka Hospital

Prague, 180 81, Czechia

Location

Hôpital Cardio-vasculaire Louis Pradel

Bron, 69677, France

Location

CHRU LILLE Hôpital Claude Huriez

Lille, 59037, France

Location

CHRU Lapeyronie

Montpellier, 34295, France

Location

Hopital Civil

Strasbourg, 67000, France

Location

Maison de santé protestante de Bordeaux Bagatelle

Talence, 33401, France

Location

Gdański Uniwersytet Medyczny

Gdansk, 80-952, Poland

Location

Instytut Medycny Wsi

Lublin, 20-090, Poland

Location

Angiodiabetica

Poznan, 61-541, Poland

Location

Warszawski Uniwersytet Medyczny

Warsaw, 02-097, Poland

Location

PODOS

Warsaw, 02-541, Poland

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Jan APELQVIST

  University Hospital of Malmö

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: January 8, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: April 1, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

CZ (5); PL (5); FR (5)