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Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcer

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Resticutis

Platelet-Poor Plasma (PPP)

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

People with Type II Diabetes mellitus between the ages of 18 and 70 with an ulcer with at least 4 weeks duration.
Hb1c of less than 13 %.
Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces), and wound area (length*width) measurement between 0.5 cm^2 and 20 cm^2, inclusive.
Wounds located under a Charcot deformity has to be free of acute changes and went through appropriate structural consolidation.
Wagner Grade II or III ulcer.
The protocol requires that post-debridement, the ulcer would be free of necrotic debris, foreign bodies, or sinus tracts.
Non invasive vascular testing Ankle Brachial Index (ABI).
Physical examination (Including a Semmes-Weinstein monofilament test for neuropathy).
Blood tests to be obtained (CBC, Hb1c)
Approved, informed, signed consent to be obtained from each patient.

Exclusion Criteria:

Patient currently enrolled in another investigative device or drug trial or previously enrolled (within the last 30 days) in an investigative research of a device or a pharmaceutical agent.
Ulcer area decreased > 50% during the seven-day screening period.
Ulcer is due to a non-diabetic etiology.
Evidence of gangrene in ulcer or on any part of the foot.
Patient is currently receiving or has received radiation or chemotherapy within the last 3 months of randomization.
Patient has received growth factor therapy within 7 days of randomization.
Screening platelets count < 100* 10^9/L.
Patient is undergoing renal dialysis, or has a known immune insufficiency, known abnormal platelets activation disorder (i.e. Grey Platelet Syndrome, Liver Disease, Active Cancer), eating/nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorder.
History of peripheral vascular repair within 30 days of randomization.
Patient is known to have a physiological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with their compliance with the study requirements and/or the healing of the ulcer.
History of alcohol or drug abuse within the last year prior to randomization.
Patient has inadequate venous access for blood withdraw.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A-Resticutis

C-Platelet-Poor Plasma PPP

Arm Description

Autologous, Activated-Platelets type of preparation.

Platelet-Poor Plasma type of preparation achieved by centrifugation of blood samples at high speed conditions. Resticutis is administered instead if the patient doesn't achieve full healing after 6 injections.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection

Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.

Secondary Outcome Measures

Assess the efficacy of autologous Resticutis injection by clinical examination

To determine short term speed and effectiveness of autologous Resticutis as a platelet lysate derivative on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the healing time.

Full Information

NCT ID

NCT02989961

First Posted

November 29, 2016

Last Updated

April 9, 2019

Sponsor

Hanan Jafar

1. Study Identification

Unique Protocol Identification Number

NCT02989961

Brief Title

Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers

Official Title

Autologous Intra-lesional Injection of Resticutis Compared to Platelet-Poor Plasma to Improve Healing of Wagner's Grade II/III Diabetic Foot Ulcers (Neuropathic/Neuro-Iscemic)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 15, 2013 (Actual)

Primary Completion Date

March 13, 2018 (Actual)

Study Completion Date

November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hanan Jafar

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.

Detailed Description

Grade II and III (According to Wagner's classification system of Ulcer severity) are considered to be of the most common complications associated with Diabetes, which are mostly hard to heal using the conventional treatment methods which by consequence severely affects the quality and lifestyle of the diabetes patient. It's thought that the application of Autologous activated platelets "Resticutis" which secretes huge amounts of growth factors is capable of giving better results of which are: the stimulation of the healing process that includes contraction, granulation, tissue formation and epithelialization of the diabetic foot ulcer. Resticutis is obtained from an autologous 20 mL peripheral blood withdrawn in tubes containing 3.8% Sodium Citrate. Blood is then centrifuged to obtain Platelet-Rich Plasma -PRP- as per established method. PRP is then activated in a closed system by physical methods to obtain a final product of 5 mL of Resticutis which is injected intra-lesionally at ulcer margins per each session of therapy. It's hypothesized that a total of six injections throughout the period of the treatment are enough to achieve full closure of the DFU. The injections are given on days: 0,14,28,42,56, and 70 of the treatment period. The consenting patients will be randomized into 2 groups: One group will be given Resticutis, and the second one Platelet-Poor Plasma PPP as placebo. If patients in PPP group didn't achieve full healing after four-six injections, they're given a two weeks rest after which they are given Resticutis instead. This is mainly a phase 1 safety study, which means no formal statistical analysis will be applied to any of the data. Safety assessment will depend on the association of any adverse events during the course of the study, and efficacy as a secondary objective will be assessed by observing the healing time of DFUs.

6. Conditions and Keywords

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

Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A-Resticutis

Arm Type

Experimental

Arm Description

Autologous, Activated-Platelets type of preparation.

Arm Title

C-Platelet-Poor Plasma PPP

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Resticutis

Other Intervention Name(s)

Actiplate 1

Intervention Description

Autologous, Activated-Platelets type of Preparation

Intervention Type

Other

Intervention Name(s)

Platelet-Poor Plasma (PPP)

Intervention Description

A preparation of low platelet plasma obtained by a high-speed centrifugation step.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection

Description

Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Assess the efficacy of autologous Resticutis injection by clinical examination

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: People with Type II Diabetes mellitus between the ages of 18 and 70 with an ulcer with at least 4 weeks duration. Hb1c of less than 13 %. Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces), and wound area (length*width) measurement between 0.5 cm^2 and 20 cm^2, inclusive. Wounds located under a Charcot deformity has to be free of acute changes and went through appropriate structural consolidation. Wagner Grade II or III ulcer. The protocol requires that post-debridement, the ulcer would be free of necrotic debris, foreign bodies, or sinus tracts. Non invasive vascular testing Ankle Brachial Index (ABI). Physical examination (Including a Semmes-Weinstein monofilament test for neuropathy). Blood tests to be obtained (CBC, Hb1c) Approved, informed, signed consent to be obtained from each patient. Exclusion Criteria: Patient currently enrolled in another investigative device or drug trial or previously enrolled (within the last 30 days) in an investigative research of a device or a pharmaceutical agent. Ulcer area decreased > 50% during the seven-day screening period. Ulcer is due to a non-diabetic etiology. Evidence of gangrene in ulcer or on any part of the foot. Patient is currently receiving or has received radiation or chemotherapy within the last 3 months of randomization. Patient has received growth factor therapy within 7 days of randomization. Screening platelets count < 100* 10^9/L. Patient is undergoing renal dialysis, or has a known immune insufficiency, known abnormal platelets activation disorder (i.e. Grey Platelet Syndrome, Liver Disease, Active Cancer), eating/nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorder. History of peripheral vascular repair within 30 days of randomization. Patient is known to have a physiological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with their compliance with the study requirements and/or the healing of the ulcer. History of alcohol or drug abuse within the last year prior to randomization. Patient has inadequate venous access for blood withdraw.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers

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