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Foot Ulcer, DiabeticADHOCNCT02334241

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

A study testing Sorbact® and Best local cares in people with Foot Ulcer, Diabetic, run by INRESA Pharma at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Foot Ulcer, Diabetic
What is being tested?
Sorbact® and Best local cares
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
15 sitesin 3 countries
Study dates
Oct 2014to Apr 2017
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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
  • Patient who are in the exclusion period following a previous participation to another trial or who are currently participating to any concomitant study with any drug or device.
  • Known intolerance to the tested medical device.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Czechia5 sites

  • Faculty of Medicine MU a FH St. Ann Brno

    Brno, 656 91

  • Cardiologic and pediatric ambulance s.r.o.

    Ostrava-vitkovice, 703 00

  • Institute for Clinical and Experimental Medicine

    Prague, 140 21

  • Podiatrie - Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha

    Prague, 169 02

  • Bulovka Hospital

    Prague, 180 81

Other trials in Czechia

France5 sites

  • Hôpital Cardio-vasculaire Louis Pradel

    Bron, 69677

  • CHRU LILLE Hôpital Claude Huriez

    Lille, 59037

  • CHRU Lapeyronie

    Montpellier, 34295

  • Hopital Civil

    Strasbourg, 67000

  • Maison de santé protestante de Bordeaux Bagatelle

    Talence, 33401

Other trials in France

Poland5 sites

  • Gdański Uniwersytet Medyczny

    Gdansk, 80-952

  • Instytut Medycny Wsi

    Lublin, 20-090

  • Angiodiabetica

    Poznan, 61-541

  • Warszawski Uniwersytet Medyczny

    Warsaw, 02-097

  • PODOS

    Warsaw, 02-541

Other trials in Poland

About this study

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

Read the detailed description

This study will select a target population of diabetic patients treated for foot ulcers of neuropathic origin, with or without arterial disease but not presenting critical limb ischaemia. No definitive wound infection should be present at inclusion. According to randomization, all present ulcers at baseline will be treated either with best local cares not including Sorbact® dressing or including systematically for all ulcers this medical device.

The main study endpoint will be a composite criterion defining a favourable limb outcome for a given patient. This criterion will be considered as present if total open wound area has decreased by 50% or more at last available evaluation whereas no definitive infection has occurred and no amputation has been required.

Patients will be followed over a maximal period of 12 weeks. At D0 (inclusion), W2, W4, W6, W8, W10 and W12 a detailed description of ulcer aspect will be done. Applied dressing will be removed according to a standardized procedure. Wound area tracing and photography of all ulcers will be performed. Off-loading system's adherence will be checked.

Between these weekly evaluations, all performed local cares will be reported and each dressing removal will be performed by using a similar procedure.

Being tested
Sorbact®, Best local cares
Keywords
Sorbact, Best local Cares, DFU
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Best local caresDevice

    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

Study groups in NCT02334241
Study groupRoleWhat they receive
Sorbact®ExperimentalThe 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.
Receives: Device: Sorbact®
Best local caresActive comparatorDressing requirements in this study have to be consistent with international guidelines.
Receives: Device: Best local cares

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Favourable healing outcome (FHO)

    A FHO is considered to have occurred in a given patient if all the following composite endpoints are met:

    1. 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.

    Measured: 12 weeks

Secondary outcomes (5)

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

    Measured: 12 weeks

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

    Measured: 12 weeks

  3. Comparative evaluation of the number of complete wound closure.

    Measured: 12 weeks

  4. 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).

    Measured: 12 weeks

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionSep 2016
  4. Study completionApr 2017

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02334241
Sponsor's protocol ID
INR 2014-001
Acronym
ADHOC
Status last verified
Aug 2017
First submitted
11 Dec 2014
Last updated
31 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Sorbact® and Best local cares in people with Foot Ulcer, Diabetic, run by INRESA Pharma at 15 sites in 3 countries.

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 14 inclusion and 13 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Czechia, France, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

Favourable healing outcome (FHO) (time frame: 12 weeks). 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 NCT02334241.

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 31 Aug 2017.

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