Isx2006 clinical case presentation

Topical Healing Botanical Preparation

Human clinical case studies involving various lesion-tissue types and comprising skin,

mucous membranes, subcutaneous tissue, muscle and bone tissue

Dr. Rodolfo Salas Auvert

PROPIETARY MATERIAL OF DR. RODOLFO SALAS AUVERT

ISX2006 is a botanical preparation of selected natural ingredients combined to generate synergistic and potentiated beneficial effects for lesion and tissue repair. The following presentation-results correspond with human clinical studies.

Cases presented comprise straight forward evolution, simple and complex clinical cases with torpid progress, given lesion nature, tissue involved and patient medical-condition.

Composition: Plantago major, Curcumin Luonga and β-(1-4)-linked D-glucosamine

(Chitosan).

Formulation: Unguent

Posology: External application to cleansed lesion area.

Therapeutics: Application to skin and mucous membranes.


Informed Consented Patients

The cases presented herein correspond with (informed consented) patients of

different age and gender, hospitalized, in-house, outpatients; and with tissue-lesions

of various nature, anatomical location, severity and etiology. The patient-lesions

treated topically with preparation ISX2006 at least once a day after wound cleansing.

The treatment goal to stimulate wound cicatrization-epithelialization by second

intention, lesion size reduction or tissue quality improvement for an early

skin graft. No antibiotic or additional co-therapy used.


Lesion Type Disease No. Cases Results

Diabetes

Ulcer Type-I 11 Satisfactory

Ulcer Type-II 27 Satisfactory

Surgical Amputation 15 Satisfactory

Burns

Thermal 2nd degree 12 Satisfactory

Thermal 3rd degree 8 Satisfactory

Ulcer Trophic 26 Satisfactory

Ulcer Ischaemic 18 Satisfactory

Plantar mal Leprosy 5 Partial results

Necrosis Ischaemic 3 Satisfactory

Necrosis Iatrogenic 1 Satisfactory

Skin Necrosis Skin Necrolysis 1 Satisfactory

Ulcer Neoplastic 2 Satisfactory

Surgical Skin Graft 12 Satisfactory

Inflammatory Hemorrhoids 35 Satisfactory

Total 176

CLINICAL CASE STUDY OF 176 INFORMED CONSENTED PATIENTS WITH VARIOUS LESION TYPES TREATED WITH ISX2006


Note: Other lesion types

treated but not accounted

for in this report comprise;

chapped lips and skin,

Insect bytes, minor skin

irritation, solar burn, tongue,

vaginal and oral mucosa

lesions, ear lesions.

Overall study results of patients with hemorrhoidal

lesions topically with preparation ISX2006

Medical

Assessment Self-Assessment

Percent Percent

Improved 78 95

appearance

Inflammation 80 90

Reduction

Pain reduction NA 97

A reduced study was undertaken to establish the potential application of preparation

ISX2006 on the symptoms and resolution of 35 patients with hemorrhoidal lesions. Two

types of lesions treated: external and internal. Internal lesions attended with the aid of a

cannula. The preparation applied twice-trice a day after anal cleansing. Progress evaluated

based on medical and patient self-assessment given improved visual appearance on

external lesions, inflammation, and pain reduction.

Disease: Enteric-Mucosal Lesion type: Hemorrhoidal tissue

Day 0 Day 5

Day 7 PROPIETARY MATERIAL OF DR. RODOLFO SALAS AUVERT

Disease: Diabetic

Lesion type: Ulcer and Surgical lesions

Study: Document diabetic lesions healing potential of preparation ISX2006

through a double-blind clinical investigation involving 31 (informed

consented) patients (11 type-I and 20 type-II diabetic patients) with

paired lesions of different size and leg location.

Goal: Study the effect of ISX2006 preparation on chronic leg lesions according

with disease classification, lesion size and healing rate. Two groups accounted

for: Test (ISX2006 treated) and Placebo (Vaseline treated).

Treatment: Preparation applied topically once a day after conventional

wound cleansing procedure. No antibiotics co-therapy involved. Wound

dressing applied when needed-required.

Data analysis: Wound photographic record established regarding measured

lesion size and clinical evolution.

Note: No adverse or allergic reaction reported.


1 2 3 4 5 6 7 8 9 10 11

Size cm2 2 3,8 1,5 3,1 2,6 3,6 4,2 1,1 1,7 2,5 2,4

Time-days 20 22 15 21 19 21 33 8 10 21 18

mm2/day 1,00 1,73 1,00 1,48 1,37 1,71 1,27 1,38 1,70 1,19 1,33

0

5

10

15

20

25

30

35

cm

2, d

ays

, m

m2

Diabetic Type-1 lesion evolution data after treatment with ISX2006

Test Avrg

Size cm2 2.59

Time 18.91

mm2/day 1.38

Basic Statistics MAX MIN Avrg

Lesion size limits (cm2) 4.20 1.10 2.59

Healing time-Days 33.00 8.00 18.91

Healing rate mm2/day 1.73 1.00 1.38

Clinical Case: Double-blind diabetic type-I ulcer patient

evolution process, treated with ISX2006


1 2 3 4 5 6 7 8 9 10 11

Size cm2 0,7 1,8 3,5 1,1 0,5 2,3 3,9 0,5 2 0,6 3,1

Time-days 21 42 56 22 29 37 41 80 15 11 69

mm2/day 0,33 0,43 0,63 0,50 0,17 0,62 0,95 0,06 1,33 0,55 0,45

0

10

20

30

40

50

60

70

80

90

cm

2, d

ays

, m

m2

Diabetic Type-1 lesion evolution data after treatment with placebo





Placebo Avrg

Size cm2 1.82

Time 38.45

mm2/day 0.55

Clinical Case: Double-blind diabetic type-I ulcer patient

evolution process, treated with placebo (Petrolatum).


MAX MIN Avrg

Lesion size limits(cm2)

4,20 1,10 2,59

Healing time-Days 33,00 8,00 18,91

Healing rate mm2/day 1,73 1,00 1,38

0,005,00

10,0015,0020,0025,0030,0035,00

cm

2, D

ays,

mm

2/d

ay Diabetic Type-1 lesion healing

statistics comparison-Test

MAX MIN Avrg


3,90 0,50 1,82



0,0010,0020,0030,0040,0050,0060,0070,0080,0090,00

cm

2, D

ays,

mm

2/d

ay Diabetic Type-1 lesion healing

statistics comparison-Placebo

Clinical Case: Comparison analysis of double-blind diabetic type-I

patient-ulcer evolution process, treated with ISX2006 and placebo


1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Size cm2 5,3 4,6 1,8 2,4 1 8,6 3,2 1,6 3,3 0,6 0,9 2,9 5,6 0,7 2,7 4,3 6,9 0,6 0,9 2,8

Time-Days 28 25 12 18 5 38 15 7 19 5 7 25 23 9 24 36 48 7 12 11

mm2/day 1,8 1,8 1,5 1,3 2,0 2,2 2,1 2,2 1,7 1,2 1,2 1,1 2,4 0,7 1,1 1,1 1,4 0,8 0,7 2,5

0

10

20

30

40

50

60

cm

2, d

ays

, m

m2

Diabetic Type-2 lesion evolution data after treatment with ISX2006





Test Avrg

Size cm2 3.04

Time 18.70

mm2/day 1.59

Clinical Case: Double-blind diabetic type-II patient

ulcer evolution process, treated with ISX2006

PROPIETARY MATERIAL OF DR. RDOLFO SALAS AUVERT

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Size cm2 1,6 3,8 2,8 1,9 0,4 1,2 2,3 0,9 2,1 1,1 0,7 1,4 2,5 1,8 0,7 1,9 4 1,1 0,4 0,9

Time-days 36 51 42 67 7 22 38 45 63 35 23 68 55 58 29 75 68 75 36 12

mm2/day 0,4 0,7 0,6 0,2 0,5 0,5 0,6 0,2 0,3 0,3 0,3 0,2 0,4 0,3 0,2 0,2 0,5 0,1 0,1 0,7

0

10

20

30

40

50

60

70

80

cm

2, d

ays

, m

m2

Diabetic Type-2 lesion evolution data after treatment with placebo

Basis Statistics MAX MIN Avrg




Placebo Avrg

Size cm2 1.68

time 45.25

mm2/day 0.40

Clinical Case: Double-blind diabetic type-II patient ulcer

evolution process, treated with placebo (Petrolatum).


MAX MIN Avrg


8,60 0,60 3,04



0,00

10,00

20,00

30,00

40,00

50,00

60,00

cm

2, D

ays

, m

m2

/da

y

Diabetic Type-2 lesion healing statistics comparison-Test

MAX MIN Avrg


3,80 0,40 1,68



0,0010,0020,0030,0040,0050,0060,0070,0080,00

cm

2, D

ays

, m

m2

/da

y

Diabetic Type-2 lesion healing statistics comparison-Placebo

Clinical Case: Comparison analysis of double-blind diabetic type-II

patient ulcer evolution process, treated with ISX2006 and placebo


Crossed double-blind diabetic type-I case study: patient with paired lesions on leg and foot,

treated with ISX2006 and placebo. Ankle lesion repair presented herein. (next case-slide

same patient)

Day 0-ISX2006 Day 20-ISX2006

Clinical Case: Diabetic type-I (Double blind)

L-foot L-foot

INFORMED CONSENTED PATIENT


Crossed double-blind diabetic type-I patient study with paired lesion on leg and foot, treated with

ISX2006 and placebo. R-leg lesion placebo treated (Petrolatum) for 26-days with no change.

Following ISX2006 lesion treatment for 21-days and complete healing at 36-days.

Day 26-Placebo Day 0-ISX2006 Day 21-ISX2006 Day 36-ISX2006

Clinical Case: Diabetic type-I (Double bind)

Day 0-Placebo R-leg

INFORMED CONSENTED PATIENT PROPIETARY MATERIAL OF DR. RODOLFO SALAS AUVERT

Diabetic type-I patient-

amputee with lesion on

left-leg (stump) treated

with ISX2006

Patient-Case: stump lesion, 3 month (hospitalized patient)

Day 0

Day 3

Day 21

Day 46

Clinical Case: Diabetic type-I patient



Diabetic type-II

patient with lesion

on R-foot external

border, treated with

ISX2006.

Day 0 Lesion age: 2 yr

Day 03

Day 06

Day 16

Clinical Case: Diabetic type-II patient

R-late

ral fo

ot



Patient-Case: foot stump lesion, 2 month (out patient)


Day 0 Day 9 Day 16

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Day 62 Day 0 Day 78

Patient-Case: foot lesion after surgical cleanup and fingers amputation


INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Cont.

Day 0 Day 92



INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Day 0 Day 67



INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: Vascular-Venous Stasis

Lesion type: Ulcer


A 2-yr venous stasis ulcerated lesion on a type-II diabetic patient, topically treated with

ISX2006. Inner R-malleolar area.

Day 0 Day 35 Day 68

Day 0 Day 35 Day 68

Clinical Case: Full thickness venous ulcer


Day 0 Day 0 Day 86 Day 86

A 10 yr venous stasis lesion on a 86-yr old female patient.

Goal: size reduction

Clinical Case: Ulcer (venous stasis)



Hypertensive female patient with a 32 yr

venous stasis ulcer. Lesion size 2x2x3¨.

Right inner supra-malleolar area.

Day 07 Day 45

Day 156

Clinical Case: Full-thickness ulcer (venous stasis)

R-lower leg



Clinical Case: Vascular-Ischemic

Lesion type: Ulcer


A 3-yr pressure ulcer lesion on a patient with transverse myelitis, and treated with ISX2006. R-ischium. Initial lesion size: depth 25 cm x 2.3 cm diam.

Day 0

Day 120

Day 120 Day 0

Day 143

Day 153

Day 143 Day 153

Clinical Case: Ulcer (Pressure-Ischemic)

R-ischium



A 1-yr hospitalized quadriplegic patient with a T-4 lesion, and multiple ischemic ulcerated full-

thickness lesions; comprising dermal, subcutaneous, muscle and bone exposure. Treatment

goal: lesion size reduction by 2nd intention to proceed with skin grafts.

Day 0

Day 04

Day 23

Day 66

Day 91

Clinical Case: Ulcer (pressure-ischemic)


Clinical Case: Iatrogenic necrosis

Lesion type: Ulcer


A 28-day lateral R-leg iatrogenic lesion on a hospitalized patient caused by oily intramuscular injection. Topically treated with ISX2006. Goal: reduce lesion size and improve tissue quality for free-skin graft surgical procedure. Note: lesion improved irrigation.

Day 0

Day 0

Day 03

Day 03

Day 27

Day 07 after skin graft

Day 27

Clinical Case: Ulcer (iatrogenic)

Lateral R-leg

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Disease: Neoplastic

Lesion type: Ulcer


Day 0 Day 10 Day 30

A recurrent

9-month

basocellular

Neoplasm ulcer-

lesion on left

supraciliary

area. Topically

treated with

ISX2006. Goal:

lesion size

reduction by 2nd

intention and

improve lesion

bed tissue

quality for

potential free-

skin graft

surgical

procedure.

Three prior

surgical

resections

Clinical Case: Ulcer (neoplasic)

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Female patient with a prior 2-yr cutaneous lymphoma and tumor lesion, and ulcer lesion after

irradiation. Lesion size: 4“ diam x 2“ depth. Goal: Lesion healing by second intention.

Day 0

Day 0

Day 180 Day 52

Day 52 Day 180

Day 302

Day 302

Clinical Case: Ulcer (Post-radiation lesion)

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: Infectious

Lesion type: Ulcer


Day 0

A 24-yr perforating plantar mal on a lepromatous leprosy patient presenting distal nerve ending obliteration and

microangiopathy (Hansen’s disease). Patient locally treated with ISX2006. Goal: lesion size reduction and tissue

quality improvement for free-skin graft surgical procedure. No further changes documented after 263 days.

Note: tissue vascularization and remodeling

Day 0

Day 91

Day 91

Day 119

Day 119

Day 190

Day 190

Day 119

Day 119

Day 263

Day 263

Clinical Case: Ulcer (Hansen´s plantar mal)

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: Toxic Epidermal Necrolysis

Lesion type: Skin Necrosis


Critical care patient with massive Toxic Epidermal Necrolysis

(TEN), topically treated with ISX2006 unguent and occlusive

dressing.

Day 0

Day 0

Day 0

Day 30 Day 30

Lo

we

r b

ack d

eta

il

Front Back Front

Front

Back


Day 0



Critical care patient with

massive cutaneous lysis

(Toxic Epidermal

Necrolysis) treated

topically with ISX2006

unguent and occlusive

dressing.

Day 0 Day 0

Day 30 Day 30 Front Back

Front Back


LESION PHOTO DETAILS


Clinical Case: Water vapor burn

Lesion type: Tissue damage and Necrosis



Clinical Cases: 2nd (2AA) degree boiling (water) liquid burn

Male patient face burn 2AA with hot water vapor, treated with ISX2006.

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Day 0 Day 3

Day 7 Day 15

Male patient face

burn 2AA with hot

water vapor, treated

with ISX2006.

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

Clinical Case: 2nd (2AA) degree boiling (water) liquid burn



Male patient face

burn 2AA with hot

water vapor,

treated with

ISX2006.

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

Clinical Cases: 2nd (2AA) degree boiling (water) liquid burn


INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

Clinical Case: 2nd (2BB) degree boiling liquid burn

Male patient L-

ventral forearm

burn 2AA with hot

water vapor,

treated with

ISX2006.


Clinical Cases: 2nd (2BB) degree boiling liquid burn

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

Male patient L-

ventral forearm

burn 2AA with hot

water vapor,

treated with

ISX2006.


Clinical Case: 2nd (2BB) degree (water) boiling liquid burn

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

Boiling liquid burn lesion with a 4-day evolution. 0-day treatment.

Boiling liquid burn lesion with a 4-day Evolution and a 5-day treatment.

Boiling liquid burn lesion with a 4-day evolution and 20-day treatment. Complete case.


Clinical Case: 2nd (2AB) degree (water) boiling liquid burn

Boiling liquid burn with 10-day evolution. 0-day treatment.



Male patient R-Dorsal upper leg burn 2AA

with hot water vapor, treated with

ISX2006.

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: 2nd (2AB) degree boiling liquid burn

Boiling liquid burn with 10-day evolution. 07-day treatment




Male patient R-Dorsal upper leg burn 2AA with hot water vapor, treated with ISX2006. INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

PROP

IETA

RY M

ATER

IAL

OF D

R. R

ODOL

FO S

ALAS

AUV

ERT

Clinical Case: 2nd (2BB) degree boiling liquid burn




Male patient ventral thorax-ventral burn 2AA

With hot water vapor, treated with ISX2006.

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: 2nd (2AB) degree mayor burn, butane gas explosion

Methane gas explosion burn, 1-day evolution. 0-day treatment. Body surface burn 60 %. 2ABA+2ABB

Methane gas explosion burn, with 1-day evolution. 3-day treatment. Body surface burn 60 %. 2ABA+2ABB





INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: 2nd (2AA) degree (water) boiling liquid burn

Water vapor burn on R-arm and chest, 1-day evolution: 2ABA. 0-day treatment.





INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: 2nd (2BB) degree gasoline flash burn

Gasoline combustion burn, 50 % body

surface lesion, 2ABB, involving trunk and

legs, 4-day evolution. 0-day treatment.











Clinical Case: 2nd (2BB) degree (liquid asphalt) burn

4-d

evol

utio

n, 0

-d tr

eatm

ent

R-forearm molten asphalt burn, 2ABB

5-d

evol

utio

n, 1

-d tr

eatm

ent

9-d

evol

utio

n, 6

-d tr

eatm

ent

19-d

evo

lutio

n, 2

2-d

trea

tmen

t


Clinical Case: 2nd (2BB) degree (liquid paint) burn

Boiling paint burn on legs, 2ABB

4-d

evol

utio

n, 0

-d tr

eatm

ent

14-d

evo

lutio

n, 1

0-d

trea

tmen

t

31-d

evo

lutio

n, 2

7-d

trea

tmen

t


Clinical Case: 2nd (2AA) degree (water) boiling liquid burn

Male patient, water vapor burn on R-external infra-malleolus

10-d

ay e

volu

tion. 00-d

ay t

reatm

ent

11-d

ay e

volu

tion. 1-d

ay t

reatm

ent

18-d

ay e

volu

tion. 7-d

ay t

reatm

ent

34-d

ay e

volu

tion. 24-d

ay t

reatm

ent

PROP

IETA

RY M

ATER

IAL

OF D

R. R

ODOL

FO S

ALAS

AUV

ERT

Clinical Case: Iatrogenic (Surgical)

Lesion type: Tissue graft (donor & receptor site)


Male patient dorsal R-leg in grand burn patient after methane gas explosion. Prior skin graft donor zone.

00-day treatment 00-day treatment after graft removal

7-day treatment

Clinical Cases: 2nd (2BB)/3rd (3AA) degree gas flash burn

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Male patient dorsal R-leg in grand burn patient after methane gas explosion. Prior skin graft donor zone.

00-day treatment 4-day treatment

Clinical Case: 2nd (2BB)/3rd (3AA) degree gas flash burn

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: 2nd (2BB)/3rd (3AA) degree gas flash burn

R-thigh dorsum after dermatome and graft

Donation, 00-day treatment.





INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: Iatrogenic

Lesion type: Post-surgical tissue necrosis


Clinical Cases: Bilateral post-mammary augmentation peri-areolar

necrosis

Photographic clinical evolution sequence of nipple-areolar necrosis

sequence during topical treatment with ISX2006. Day-0 before necrectomy

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT


Clinical Case: Bilateral post-mammary augmentation peri-areolar

necrosis


sequence during topical treatment with ISX2006. L-Breast. After necrectomy.




necrosis


sequence during topical treatment with ISX2006. R-Breast. After necrectomy.

Note: high rate tissue epithelization-recuperation cm/day



necrosis

Photographic clinical evolution sequence of nipple-areolar sequence

before-after topical treatment with ISX2006. After necrectomy.



necrosis


during topical treatment with ISX2006. R-Breast.

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

PROP

IETA

RY M

ATER

IAL

OF D

R. R

ODOL

FO S

ALAS

AUV

ERT


necrosis


during topical treatment with ISX2006. L-Breast.

INF

OR

ME

D C

ON

SE

NT

ED

PA

TIE

NT

PR

OPIE

TARY

MAT

ERIA

L OF

DR.

RDO

OLFO

SAL

AS A

UVER

T

Clinical Case: Post-surgical dehisence after compound tibia fracture.

Left leg. Topical treatment with ISX2006, cont.


Clinical Case: Post-surgical dehisence after compound tibia fracture.

Left leg. Topical treatment with ISX2006.



1. Promotes tissue granulation-epithelization of various

wound types and severity.

2. Healing effect can be extended to mucous membranous, skin,

subcutaneous tissue, muscle and bone.

3. Generates local vasodilation and increased blood irrigation

4. Non-steroidal anti-inflammatory activity.

5. Minimized fibrotic eschar tissue formation.

The conclusions presented herein correspond with

clinical observations documented in the various cases

treated with preparation ISX2006.

Conclusions


Isx2006 clinical case presentation

Health & Medicine

Transcript of Isx2006 clinical case presentation