TerminatedNCT01679678Updated Mar 30, 2016

A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen

A Phase 2 interventional study of PolyHeal 2 and Polyheal in Surgical Wound Dehiscence, sponsored by MediWound Ltd. Terminated at 4 sites in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-03-30.

Sponsored by MediWound Ltd · Phase 2, Interventional, and Treatment

Why this study was terminated

Business considerations

Phase: Phase 2
Study type: Interventional
Enrollment: 15
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.

Read the detailed description

Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks.

Continuation of study device for additional period is based on wound healing progression and under investigator's discretion.

Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.

Conditions studied

Surgical Wound Dehiscence

Browse trials for

In context

Surgical Wound Dehiscence

43 studies on the registry are indexed under Surgical Wound Dehiscence; 12 are open to participants now.

This study's enrollment of 15 is below the median of 65 across 33 interventional studies indexed under Surgical Wound Dehiscence.

Browse Surgical Wound Dehiscence studies →

Lead sponsor

MediWound Ltd is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent)
Subjects who are able to read, understand, and sign the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required.

Exclusion criteria

Exclusion Criteria:

Presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
Wounds with exposed bones, tendons or ligaments
Wounds with exposed orthopedic implants
Wounds with exposed breast prostheses
Uncontrolled diabetes with HbA1c >11%
Subjects with BMI greater than 35kg/m2
Woman who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
Participation in another clinical drug/device trial within 30 days prior to the Screening visit or during this study

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 15 participants (actual)

Study arms

Experimental
PolyHeal 2
Negatively charged 5-micron polystyrene microspheres in Water For Injection
Device: PolyHeal 2
Active comparator
PolyHeal
Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)
Device: Polyheal

Interventions

DevicePolyHeal 2
PolyHeal is a sterile medical device
Also known as: PolyHeal, PolyHeal is a sterile medical device
DevicePolyheal
PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
Also known as: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM

What researchers measure

Primary outcomes

Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
Time frame: 4 weeks

Study locations

4 sites

Soroka Medical Center
Beer Sheva, Israel
Rambam Medical Center
Haifa, Israel
Western Galilee Hospital
Naharia, Israel
Souraski Medical Center
Tel Aviv, Israel

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01679678
Lead sponsor: MediWound Ltd
Responsible party: Sponsor
First posted: Sep 6, 2012
Start date: Nov 2012
Primary completion: Aug 2014
Completion: Aug 2014
Last update: Mar 30, 2016

Study contacts

Alex Berezovsky, MD

principal investigator · Head of Department of Plastic and reconstructive surgery

Eyal Gur, MD

principal investigator · Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center

Leonid Kogan, MD

principal investigator · Head of Plastic Surgery Department Western Galilee Hospital

Yehuda Ulman, Proffesor

principal investigator · Head of Plastic surgery department ,Rambam Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Surgical Wound Dehiscence→

Other studies from this sponsor

MediWound Ltd

Start the discussion