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

NCT01679678 | Terminated Phase 2

• 1 other identifier: MWPH-2012-08-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Surgical Wound Dehiscence

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Study Arms (2)

PolyHeal 2

EXPERIMENTAL

Negatively charged 5-micron polystyrene microspheres in Water For Injection

Device: PolyHeal 2

PolyHeal

ACTIVE COMPARATOR

Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)

Device: Polyheal

Interventions

PolyHeal 2 DEVICE

PolyHeal is a sterile medical device

Also known as: PolyHeal, PolyHeal is a sterile medical device

PolyHeal 2

Polyheal DEVICE

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

PolyHeal

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (4)

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Western Galilee Hospital

Nahariya, Israel

Location

Souraski Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex Berezovsky, MD

  Head of Department of Plastic and reconstructive surgery

  PRINCIPAL INVESTIGATOR

• Eyal Gur, MD

  Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center

  PRINCIPAL INVESTIGATOR

• Leonid Kogan, MD

  Head of Plastic Surgery Department Western Galilee Hospital

  PRINCIPAL INVESTIGATOR

• Yehuda Ulman, Proffesor

  Head of Plastic surgery department ,Rambam Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: September 6, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

IL (4)